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Safety & Efficacy of the Laser Scleral Microporation Procedure (Taiwan)

Primary Purpose

Presbyopia

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser Scleral Microporation
Sponsored by
ACE Vision Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia, Sclera, Laser Scleral Microporation

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Willing and able to understand and sign an informed consent;
  2. Willing and able to attend postoperative examinations per protocol schedule;
  3. 45 years of age or greater, of either gender or any race;
  4. Less than (<) 1.00D of astigmatism in each eye, measured in their manifest refraction;
  5. Mean refractive spherical equivalent refraction (MRSE) of +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery (LASIK, LASEK or PRK) may qualify; however, the subject must have had the LVC procedure performed at least 12 months prior to the Laser Scleral Microporation procedure and be stable.
  6. Uncorrected distance visual acuity (UDVA) is better than or equal to 20/40 (logMAR 0.30) in each eye, and a Corrected Distance Visual Acuity (CDVA) is better than or equal to 20/25 (logMAR 0.10) in each eye;
  7. Demonstrate Stereopsis of 100 seconds of arc or better using a Randot stereoscopic fly test and reading correction;
  8. In good ocular health with the exception of presbyopia;
  9. Presbyopia as demonstrated by:

    1. Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more at 40 cm in each eye; and
    2. Reduced near visual acuity at 40 cm when corrected for distance (DCNVA) of 20/50 (logMAR 0.40) or worse in each eye;
  10. Intraocular pressure (IOP) >11mmHg and < 30 mmHg in each eye without IOP-lowering medication;
  11. Less than or equal to (≤) 0.50D difference between the manifest refraction and the cycloplegic refraction;
  12. Stable distance refraction is present, defined as ≤ 0.50D variation of refraction in the 12 months prior to the Laser Scleral Microporation procedure. Manifest refraction cannot vary more than 0.50D from current spectacles that are at least 12 months of age, or from a documented refraction at least 12 months prior to the preoperative baseline exam; if baseline data is available.
  13. Completed a washout period of two weeks (14 days) prior to Laser Scleral Microporation procedure from prior treatment with:

    • With prior medical clearance: NSAIDS, blood thinners, aspirin, and other substances which may increase bleeding;
    • Anti-oxidants, which could affect blood thinning14

      • Any anti-oxidant supplements (e.g., Vitamin B6, Vitamin B12, Vitamin E, Vitamin C, Acai, Ocuvite, etc);
      • Anti-oxidant food supplements, such as shitake mushroom, mushroom extract and oral anti-oxidants.

Exclusion Criteria:

  1. Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;
  2. History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;
  3. Presence of ocular pathology other than cataract such as:

    • Amblyopia or strabismus
    • Corneal abnormalities or disease
    • Dry Eye, presenting with corneal staining15
    • Pupil abnormalities (e.g., corectopia, Adie's)
    • Capsule or zonular abnormalities
    • Intraocular inflammation
    • Retinal disease or pathology
    • Glaucoma (any type)
    • History of prior ocular surgery other than keratorefractive surgery;
  4. Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 (logMAR 0.18) or worse (e.g., macular degeneration);
  5. Previous corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK;
  6. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy);
  7. Keratoconus or keratoconus suspect with CDVA of less than (<) 20/20 (< logMAR 0.00) at distance;
  8. Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);
  9. Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);
  10. Acute or chronic disease or illness that could increase the operative risk or confound the study outcome(s) (e.g., diabetes mellitus, immunocompromised, connective tissue disease);
  11. Uncontrolled systemic or ocular disease;
  12. Any abnormality preventing reliable applanation tonometry in EITHER eye;
  13. Undilatable pupil such that one cannot examine the periphery of the retina;
  14. Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.
  15. History of scleral ectasia, scleritis, or episcleritis
  16. History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA;
  17. Known allergies to study medications including topical steroids, antibiotics and NSAIDS;
  18. Too thin sclera thickness
  19. Per PI discretion, as described below:

Sites / Locations

  • Chang Gung Memorial Hospital, Keelung
  • Chang Gung Memorial Hospital, Linkou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser Scleral Microporation procedure

Arm Description

Patients suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure.

Outcomes

Primary Outcome Measures

Binocular Uncorrected Near Visual Acuity (UNVA) @ 40cm
Binocular UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is performed under photopic lighting conditions.

Secondary Outcome Measures

Patient Self-Reporting Questionnaire 1
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified Near Activity Visual Questionnaire (NAVQ) will be used [see citation 1, Buckhurst et al.]. This questionnaire consists of 10 questions. Each question can be answered with scores between 0 (best outcome and 3 (worst outcome). The answers will be converted to Rasch score according to the NAVQ guidelines.
Patient Self-Reporting Questionnaire 2
A self-reporting questionnaire will be used to assess adverse events and side effects.
Monocular & Binocular Uncorrected Distance Visual Acuity (UDVA) @ 4m
UDVA is measured with ETDRS charts placed in 4m distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Monocular & Binocular Uncorrected Intermediate Visual Acuity (UIVA) @ 60cm
UIVA is measured with ETDRS charts placed in 60cm distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Monocular & Binocular Uncorrected Near Visual Acuity (UNVA) @ 40cm
UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Manifest Refraction
This is the manual way to determine the best lenses, by placing carious lenses in front of the subject's eyes and asking questions by using a phoropter. Perform maximum plus subjective refraction with 100% contrast ETDRS cart at 4m. The data contains value for sphere, cylinder and axis cylinder. This assessment is performed under photopic lighting conditions
Monocular & Binocular Best Corrected Distance Visual Acuity (CDVA) @ 4m
CDVA is measured with ETDRS charts placed in 4m distance using best aided corrective glasses. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Monocular & Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @ 60cm
DCIVA is measured with ETDRS charts placed in 60cm distance using corrective glasses for far distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Monocular & Binocular Distance Corrected Near Visual Acuity (DCNVA) @ 40cm
DCNVA is measured with ETDRS charts placed in 40cm distance using corrective glasses for far distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Determination of reading prescription
Subjects will be refracted at 40cm based upon distance prescription. The subject holds a near card (Chart 1) at 40cm. With the subject's binocular distance refraction in place, plus power is increased in +0.25 increments binocularly until the subject can read the 0.0 logMAR line on the chart. If the subject cannot read the logMAR 0.0 line with a +2.5D ADD, +2.5D ADD with the visual acuity will be recorded. This assessment will be performed under photopic lighting conditions.
Accommodative Amplitude using binocular & monocular minus lens to blur
The amplitude of accommodation will be assessed at distance with introduction of minus power over the distance prescription to stimulate accommodation. The subject will be instructed to focus on the distance Hart chart and slowly add minus power in -0.25D steps until the subject reports first sustained blur on the line. Record the dioptric value where the subject reports the first sustained blur. Subtract the distance prescription from this value to obtain the accommodative amplitude using this method. This test is repeated three times. This assessment is performed binocularly, then monocularly under photopic lighting conditions.
iReST reading test
The reading speed will be measured using the International Reading Speed Texts (iReST™), a standardized assessment of reading speed. For this test, the reading prescription determined at each visit will be used and the assessment will be performed under photopic lighting conditions.
Wavefront Aberrometry
The iTrace (Tracey Technologies, Houston, TX) measures aberrometry at distance, 60cm and 40cm. Measurements will be performed uncorrected and corrected aided using the distance prescription based upon the manifest refraction. Coma, Spherical Aberration, and Trefoil exams will also be recorded at distance, 60cm and 40cm.
Auto-Keratometry
An auto keratometer uses a microprocessor computer to facilitate the rapid measurement of the corneal curvature. The simulated keratometry (Sim K) us determined as the average keratometry, calculated by using the standard keratometric index and the radius of anterior corneal curvature using the the iTrace (Tracey Technologies, Houston TX).
Corneal Topography
Corneal topography is a computer assisted diagnostic tool that creates a three-dimensional map of the surface curvature of the cornea. Anterior surface corneal topography using placido disc will be measured using the iTrace unit (Tracey Technologies, Houston, TX).
Speedy-i Accommodation Testing
Speedy-i is used for accommodation test and subject's individual Accommodative Micro Fluctuation (AMF) is analyzed.
Stereoacuity
Stereoacuity will be measured under photopic conditions using a standard randot stereoscopic test at 40cm with the subject's reading prescription (determined at each visit). This assessment will be performed under photopic lighting conditions.
Pupillometry
Measurement of pupil size will be performed under photopic and mesopic lighting conditions. The Neuroptics VIP® -200 pupillometer or equivalent is being used.
Contrast Sensitivity
Contrast sensitivity is the subject's ability to distinguish the foreground from the background. This will be measured using ETDRS (Precision Vision Chart 2153) optotypes (5 per acuity level) with 10% contrast placed in 4m distance. Distance prescription should be worn. This assessment will be performed monocularly, then binocularly under photopic lighting conditions.
Axial Length Measurement
The length of the globe, or "axial length" will be measured using a non-contact optical low-coherence reflectometry. Recommended devices LENSTAR LS900, Alcom) or (IOLMaster version 7.5 or higher, Carl Zeiss Humphrey).
Slit Lamp Examination
The slit lamp examination is one examination to analyse the integrity of the eye structures. With the slit lamp the ophthalmologist can observe the eyes stereoscopically. A focused slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slit lamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slit lamp: Corneal clarity anterior chamber cells anterior chamber flare lens grading using the LOCS III score card Conjunctival/scleral vessel injection Degree of choroidal hue Conjunctival edema Conjunctival hemorrhages Other corneal/conjunctival/scleral observations Dry Eye Other anterior chamber observations Eyelid edema
Intraocular Pressure Measurement
Intraocular Pressure will be measured using Goldmann applanation tonometry. Two measurements will be performed per eye at each visit. If there is more than 2mmHg between the two reading, a third reading will be performed. The value will be an average.
Cycloplegic refraction
A cycloplegic refraction at distance using 1% cyclopentolate will be performed to determine the absolute refractive error.
Dilated Fundus exam
A Dilated Fundus Exam will also be performed to examine the vitreous, optic nerve, blood vessels, macula and retina to identify eye related diseases or anatomical anomalies.

Full Information

First Posted
November 1, 2019
Last Updated
August 2, 2022
Sponsor
ACE Vision Group, Inc.
Collaborators
Vision Renu Taiwan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04151446
Brief Title
Safety & Efficacy of the Laser Scleral Microporation Procedure (Taiwan)
Official Title
Evaluation of the Safety & Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Inadequate Enrollment
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACE Vision Group, Inc.
Collaborators
Vision Renu Taiwan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment.
Detailed Description
This is a prospective, controlled, single-center clinical study to evaluate the safety and efficacy of the Laser Scleral Microporation Procedure. Laser Scleral Microporation Procedure is a treatment to restore visual and accommodative function in presbyopic patients. The subjects are bilaterally treated with the Laser Scleral Microporation procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia, Sclera, Laser Scleral Microporation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Scleral Microporation procedure
Arm Type
Experimental
Arm Description
Patients suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure.
Intervention Type
Device
Intervention Name(s)
Laser Scleral Microporation
Intervention Description
Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.
Primary Outcome Measure Information:
Title
Binocular Uncorrected Near Visual Acuity (UNVA) @ 40cm
Description
Binocular UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is performed under photopic lighting conditions.
Time Frame
12 months postoperative
Secondary Outcome Measure Information:
Title
Patient Self-Reporting Questionnaire 1
Description
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified Near Activity Visual Questionnaire (NAVQ) will be used [see citation 1, Buckhurst et al.]. This questionnaire consists of 10 questions. Each question can be answered with scores between 0 (best outcome and 3 (worst outcome). The answers will be converted to Rasch score according to the NAVQ guidelines.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Patient Self-Reporting Questionnaire 2
Description
A self-reporting questionnaire will be used to assess adverse events and side effects.
Time Frame
3 Day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Monocular & Binocular Uncorrected Distance Visual Acuity (UDVA) @ 4m
Description
UDVA is measured with ETDRS charts placed in 4m distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Monocular & Binocular Uncorrected Intermediate Visual Acuity (UIVA) @ 60cm
Description
UIVA is measured with ETDRS charts placed in 60cm distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Monocular & Binocular Uncorrected Near Visual Acuity (UNVA) @ 40cm
Description
UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Manifest Refraction
Description
This is the manual way to determine the best lenses, by placing carious lenses in front of the subject's eyes and asking questions by using a phoropter. Perform maximum plus subjective refraction with 100% contrast ETDRS cart at 4m. The data contains value for sphere, cylinder and axis cylinder. This assessment is performed under photopic lighting conditions
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Monocular & Binocular Best Corrected Distance Visual Acuity (CDVA) @ 4m
Description
CDVA is measured with ETDRS charts placed in 4m distance using best aided corrective glasses. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Monocular & Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @ 60cm
Description
DCIVA is measured with ETDRS charts placed in 60cm distance using corrective glasses for far distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Monocular & Binocular Distance Corrected Near Visual Acuity (DCNVA) @ 40cm
Description
DCNVA is measured with ETDRS charts placed in 40cm distance using corrective glasses for far distance. This assessment is performed monocularly, then binocularly under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Determination of reading prescription
Description
Subjects will be refracted at 40cm based upon distance prescription. The subject holds a near card (Chart 1) at 40cm. With the subject's binocular distance refraction in place, plus power is increased in +0.25 increments binocularly until the subject can read the 0.0 logMAR line on the chart. If the subject cannot read the logMAR 0.0 line with a +2.5D ADD, +2.5D ADD with the visual acuity will be recorded. This assessment will be performed under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months ; 12 months; 18 months & 24 months postoperative
Title
Accommodative Amplitude using binocular & monocular minus lens to blur
Description
The amplitude of accommodation will be assessed at distance with introduction of minus power over the distance prescription to stimulate accommodation. The subject will be instructed to focus on the distance Hart chart and slowly add minus power in -0.25D steps until the subject reports first sustained blur on the line. Record the dioptric value where the subject reports the first sustained blur. Subtract the distance prescription from this value to obtain the accommodative amplitude using this method. This test is repeated three times. This assessment is performed binocularly, then monocularly under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
Title
iReST reading test
Description
The reading speed will be measured using the International Reading Speed Texts (iReST™), a standardized assessment of reading speed. For this test, the reading prescription determined at each visit will be used and the assessment will be performed under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
Title
Wavefront Aberrometry
Description
The iTrace (Tracey Technologies, Houston, TX) measures aberrometry at distance, 60cm and 40cm. Measurements will be performed uncorrected and corrected aided using the distance prescription based upon the manifest refraction. Coma, Spherical Aberration, and Trefoil exams will also be recorded at distance, 60cm and 40cm.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Auto-Keratometry
Description
An auto keratometer uses a microprocessor computer to facilitate the rapid measurement of the corneal curvature. The simulated keratometry (Sim K) us determined as the average keratometry, calculated by using the standard keratometric index and the radius of anterior corneal curvature using the the iTrace (Tracey Technologies, Houston TX).
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Corneal Topography
Description
Corneal topography is a computer assisted diagnostic tool that creates a three-dimensional map of the surface curvature of the cornea. Anterior surface corneal topography using placido disc will be measured using the iTrace unit (Tracey Technologies, Houston, TX).
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Speedy-i Accommodation Testing
Description
Speedy-i is used for accommodation test and subject's individual Accommodative Micro Fluctuation (AMF) is analyzed.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
Title
Stereoacuity
Description
Stereoacuity will be measured under photopic conditions using a standard randot stereoscopic test at 40cm with the subject's reading prescription (determined at each visit). This assessment will be performed under photopic lighting conditions.
Time Frame
1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Pupillometry
Description
Measurement of pupil size will be performed under photopic and mesopic lighting conditions. The Neuroptics VIP® -200 pupillometer or equivalent is being used.
Time Frame
1 day, 3 day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Contrast Sensitivity
Description
Contrast sensitivity is the subject's ability to distinguish the foreground from the background. This will be measured using ETDRS (Precision Vision Chart 2153) optotypes (5 per acuity level) with 10% contrast placed in 4m distance. Distance prescription should be worn. This assessment will be performed monocularly, then binocularly under photopic lighting conditions.
Time Frame
1 month; 12 months & 24 months postoperative
Title
Axial Length Measurement
Description
The length of the globe, or "axial length" will be measured using a non-contact optical low-coherence reflectometry. Recommended devices LENSTAR LS900, Alcom) or (IOLMaster version 7.5 or higher, Carl Zeiss Humphrey).
Time Frame
1 month; 12 months & 24 months postoperative
Title
Slit Lamp Examination
Description
The slit lamp examination is one examination to analyse the integrity of the eye structures. With the slit lamp the ophthalmologist can observe the eyes stereoscopically. A focused slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slit lamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slit lamp: Corneal clarity anterior chamber cells anterior chamber flare lens grading using the LOCS III score card Conjunctival/scleral vessel injection Degree of choroidal hue Conjunctival edema Conjunctival hemorrhages Other corneal/conjunctival/scleral observations Dry Eye Other anterior chamber observations Eyelid edema
Time Frame
1 day, 3 days, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Intraocular Pressure Measurement
Description
Intraocular Pressure will be measured using Goldmann applanation tonometry. Two measurements will be performed per eye at each visit. If there is more than 2mmHg between the two reading, a third reading will be performed. The value will be an average.
Time Frame
1 day, 3 days, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
Title
Cycloplegic refraction
Description
A cycloplegic refraction at distance using 1% cyclopentolate will be performed to determine the absolute refractive error.
Time Frame
1 month; 12 months & 24 months postoperative
Title
Dilated Fundus exam
Description
A Dilated Fundus Exam will also be performed to examine the vitreous, optic nerve, blood vessels, macula and retina to identify eye related diseases or anatomical anomalies.
Time Frame
1 month; 12 months & 24 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to understand and sign an informed consent; Willing and able to attend postoperative examinations per protocol schedule; 45 years of age or greater, of either gender or any race; Less than (<) 1.00D of astigmatism in each eye, measured in their manifest refraction; Mean refractive spherical equivalent refraction (MRSE) of +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery (LASIK, LASEK or PRK) may qualify; however, the subject must have had the LVC procedure performed at least 12 months prior to the Laser Scleral Microporation procedure and be stable. Uncorrected distance visual acuity (UDVA) is better than or equal to 20/40 (logMAR 0.30) in each eye, and a Corrected Distance Visual Acuity (CDVA) is better than or equal to 20/25 (logMAR 0.10) in each eye; Demonstrate Stereopsis of 100 seconds of arc or better using a Randot stereoscopic fly test and reading correction; In good ocular health with the exception of presbyopia; Presbyopia as demonstrated by: Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more at 40 cm in each eye; and Reduced near visual acuity at 40 cm when corrected for distance (DCNVA) of 20/50 (logMAR 0.40) or worse in each eye; Intraocular pressure (IOP) >11mmHg and < 30 mmHg in each eye without IOP-lowering medication; Less than or equal to (≤) 0.50D difference between the manifest refraction and the cycloplegic refraction; Stable distance refraction is present, defined as ≤ 0.50D variation of refraction in the 12 months prior to the Laser Scleral Microporation procedure. Manifest refraction cannot vary more than 0.50D from current spectacles that are at least 12 months of age, or from a documented refraction at least 12 months prior to the preoperative baseline exam; if baseline data is available. Completed a washout period of two weeks (14 days) prior to Laser Scleral Microporation procedure from prior treatment with: With prior medical clearance: NSAIDS, blood thinners, aspirin, and other substances which may increase bleeding; Anti-oxidants, which could affect blood thinning14 Any anti-oxidant supplements (e.g., Vitamin B6, Vitamin B12, Vitamin E, Vitamin C, Acai, Ocuvite, etc); Anti-oxidant food supplements, such as shitake mushroom, mushroom extract and oral anti-oxidants. Exclusion Criteria: Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period; History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention; Presence of ocular pathology other than cataract such as: Amblyopia or strabismus Corneal abnormalities or disease Dry Eye, presenting with corneal staining15 Pupil abnormalities (e.g., corectopia, Adie's) Capsule or zonular abnormalities Intraocular inflammation Retinal disease or pathology Glaucoma (any type) History of prior ocular surgery other than keratorefractive surgery; Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 (logMAR 0.18) or worse (e.g., macular degeneration); Previous corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK; Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy); Keratoconus or keratoconus suspect with CDVA of less than (<) 20/20 (< logMAR 0.00) at distance; Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range); Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated); Acute or chronic disease or illness that could increase the operative risk or confound the study outcome(s) (e.g., diabetes mellitus, immunocompromised, connective tissue disease); Uncontrolled systemic or ocular disease; Any abnormality preventing reliable applanation tonometry in EITHER eye; Undilatable pupil such that one cannot examine the periphery of the retina; Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression. History of scleral ectasia, scleritis, or episcleritis History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA; Known allergies to study medications including topical steroids, antibiotics and NSAIDS; Too thin sclera thickness Per PI discretion, as described below:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ma, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arvin Sun, MD
Organizational Affiliation
Chang Gung Memorial Hospital, Keelung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Keelung
City
Keelung
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22078121
Citation
Buckhurst PJ, Wolffsohn JS, Gupta N, Naroo SA, Davies LN, Shah S. Development of a questionnaire to assess the relative subjective benefits of presbyopia correction. J Cataract Refract Surg. 2012 Jan;38(1):74-9. doi: 10.1016/j.jcrs.2011.07.032. Epub 2011 Nov 10.
Results Reference
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Safety & Efficacy of the Laser Scleral Microporation Procedure (Taiwan)

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