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Use of the VisuMax™ Femtosecond Laser

Primary Purpose

Myopia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Treatment with the VisuMax™ Femtosecond Laser

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female subjects age 22 years of age and older;
Spherical myopia from ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated;
A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated;
A difference between cycloplegic and manifest refractions of < 0.75 D spherical equivalent in the eye to be treated;
UCVA worse than 20/40 in the eye to be treated;
BSCVA at least 20/20 in the eye to be treated;
Discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the preoperative examination, and through the day of surgery;
All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated;
Central corneal thickness of at least 500 microns in the eye to be treated;
Willing and able to return for scheduled follow-up examinations;
Able to provide written informed consent and follow study instructions in English.

Exclusion Criteria:

Mesopic pupil diameter > 8.0 mm;
Cylinder > -0.50 D;
Treatment depth is less than 250 microns from the corneal endothelium;
Eye to be treated is targeted for monovision;
Fellow eye has BSCVA worse than 20/40;
Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
History of or current anterior segment pathology, including cataracts in the eye to be treated;
Clinically significant dry eye syndrome unresolved by treatment in either eye;
Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye to be treated;
Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
History of ocular herpes zoster or herpes simplex keratitis;
Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
Difficulty following directions or unable to fixate;
Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes;
History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye;
History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
History of known sensitivity to planned study medications;
Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.

Sites / Locations

Dishler Laser Institute
Bascom Palmer Eye Institute
Discover Vision Centers
Vance Thompson Vision
Davis Duehr Dean

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment of Myopia

Arm Description

The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.

Outcomes

Primary Outcome Measures

Effectiveness- Predictability

Number of participants with a decrease in manifest refraction spherical equivalent (MRSE) to within ± 1.00 D and ± 0.50 D of the intended refractive outcome at the point at which stability is first reached. The MRSE is the amount of prescription needed to obtain your best corrected vision as compared to your preoperative best corrected vision. A minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome.

Effectiveness- Improvement in UCVA Following Treatment

Number of participants with uncorrected visual acuity (UCVA) of 20/40 or better at the point of stability. .This is vision without any form of prescription. A target of 85% of participants is required.

Stability Criteria- Change Between Visits Within 1.00 Diopter (D)

Number of participants with a change in postoperative refraction within 1.00 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.

Safety- Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)

Number of participants with worse than 20/40 visual acuity with a preoperative BSCVA (Best Spectacle Corrected Visual Acuity) 20/20 or better. Target is less than 1% of study participants. Less than 5% of participants with BCVA loss ≥ 2 lines

Safety- Induced Manifest Refractive Astigmatism

Number of participants with an increase of astigmatism of greater than 2.00 D cylinder from the preoperative values. Target is less than 5% of participants.

Safety- Adverse Events

Number of participants for each type of adverse event. Target of less than 1% of participants for each type of adverse event.

Safety- Contrast Sensitivity

Number of participants who increased, remained the same, and decreased in contrast sensitivity. There are 4 different frequencies (1.5, 3.0, 6.0, and 12.0) which will be tested and are more difficult to detect as the frequency number increases.

Stability Criteria- Change Between Visits Within 0.50 Diopter (D)

Number of participants with a change in postoperative refraction within 0.50 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.

Secondary Outcome Measures

Safety- Patient Symptoms

A standardized quality of vision (QoV) questionnaire was used in the study. A score is generated and was used to compare the results from baseline to the 12 month visit. Number of participants who improved, stayed the same, or worsened with regards to the frequency, severity, and bothersomeness of symptoms are reported.

Full Information

NCT ID

NCT01638390

First Posted

July 2, 2012

Last Updated

December 12, 2018

Sponsor

Carl Zeiss Meditec, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01638390

Brief Title

Use of the VisuMax™ Femtosecond Laser

Official Title

Use of the VisuMax™ Femtosecond Laser Lenticule Removal Procedure for the Correction of Myopia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Carl Zeiss Meditec, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE (Manifest Refractive Spherical Equivalent) ≤ -8.25 D.

Detailed Description

This is a prospective multi-center clinical trial in which a total of 360 eyes of consecutive subjects will be enrolled, treated with the VisuMax™ Femtosecond Laser, and followed for a 12-month period. The study will be conducted at up to 8 clinical sites. Enrollment will be phased such that 100 eyes will be initially enrolled and followed. When 50 of the initial eyes have reached the 3-month follow-up exam, an interim clinical study report will be submitted to FDA along with a request to continue enrollment up to 360 eyes. Subjects will be screened for eligibility, and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline ocular condition. Baseline and postoperative measurements will include manifest refraction, cycloplegic refraction, distance visual acuity (best corrected and uncorrected), slit-lamp examination, fundus examination, corneal topography, central corneal pachymetry, mesopic pupil measurement, wavefront analysis, mesopic contrast sensitivity, and intraocular pressure (IOP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

357 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment of Myopia

Arm Type

Other

Arm Description

The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.

Intervention Type

Device

Intervention Name(s)

Treatment with the VisuMax™ Femtosecond Laser

Other Intervention Name(s)

VisuMaxTM Femtosecond Laser

Intervention Description

The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.

Primary Outcome Measure Information:

Title

Effectiveness- Predictability

Description

Time Frame

12 months

Title

Effectiveness- Improvement in UCVA Following Treatment

Description

Time Frame

12 month

Title

Stability Criteria- Change Between Visits Within 1.00 Diopter (D)

Description

Number of participants with a change in postoperative refraction within 1.00 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.

Time Frame

6 months

Title

Safety- Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)

Description

Time Frame

12 months

Title

Safety- Induced Manifest Refractive Astigmatism

Description

Number of participants with an increase of astigmatism of greater than 2.00 D cylinder from the preoperative values. Target is less than 5% of participants.

Time Frame

12 months

Title

Safety- Adverse Events

Description

Number of participants for each type of adverse event. Target of less than 1% of participants for each type of adverse event.

Time Frame

12 months

Title

Safety- Contrast Sensitivity

Description

Time Frame

12 months

Title

Stability Criteria- Change Between Visits Within 0.50 Diopter (D)

Description

Number of participants with a change in postoperative refraction within 0.50 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Safety- Patient Symptoms

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects age 22 years of age and older; Spherical myopia from ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated; A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated; A difference between cycloplegic and manifest refractions of < 0.75 D spherical equivalent in the eye to be treated; UCVA worse than 20/40 in the eye to be treated; BSCVA at least 20/20 in the eye to be treated; Discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the preoperative examination, and through the day of surgery; All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated; Central corneal thickness of at least 500 microns in the eye to be treated; Willing and able to return for scheduled follow-up examinations; Able to provide written informed consent and follow study instructions in English. Exclusion Criteria: Mesopic pupil diameter > 8.0 mm; Cylinder > -0.50 D; Treatment depth is less than 250 microns from the corneal endothelium; Eye to be treated is targeted for monovision; Fellow eye has BSCVA worse than 20/40; Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye; History of or current anterior segment pathology, including cataracts in the eye to be treated; Clinically significant dry eye syndrome unresolved by treatment in either eye; Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye to be treated; Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye; Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye; History of ocular herpes zoster or herpes simplex keratitis; Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction; Difficulty following directions or unable to fixate; Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes; History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye; History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome; Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing; History of known sensitivity to planned study medications; Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation; Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.

Overall Study Officials: