Back to resultsStudy of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery
Primary Purpose
Cataract, Presbyopia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)
Use Monofocal intraocular lenses(IOLs)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Post-corneal Refractive Surgery, Presbyopia-correcting IOL, Cataract, Efficiency, Safety
Eligibility Criteria
Inclusion Criteria:
- The operated eye has ever undergone corneal refractive surgery, including PRK, LASIK, LASEK, FS-LASIK, SMILE and excluding RK
- At least one eye suffering from cataract and expected to undergo phacoemulsification and IOL implantation and cataract nuclei rigidity in the operated eye from 1 to 3 degree
- Expected to use intraocular lens power in -10.0D~+30.0D
- Willing and able to comply with scheduled visits and other study procedures.
- The need to decrease the dependence of glasses
- Signing an informed consent form
Exclusion Criteria:
- Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
- Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
- The density of corneal endothelial cells is lower than 2000/mm2
- The natural diameter of the pupil under the darkroom is less than 3mm or greater than 5.5mm
- The Kappa or Alpha angle of the operated eye is greater than 0.5mm, or the Kappa angle is greater than half of the diameter of the central refractive optical zone in the multifocal intraocular lens
- Patients with expected best corrected distance visual acuity(BCDVA) less than 0.5 (decimal vision)
- Occurrence of irregular corneal astigmatism that affects postoperative vision
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye
- Pregnant, lactation or planning to become pregnant in the near future
- Any surgical contraindications
- Uncontrolled systemic or ocular disease
- Use of any systemic or topical drug known to interfere with visual performance
- Other ocular surgery at the time of the cataract extraction
- Traumatic cataract or congenital bilateral cataract in the operated eye
- Getting used to reading with glasses
- High requirements for visual functions in patients' career or daily life
- Professional drivers or frequent outdoor workers at night
- A medical history of photophobia
- Amblyopia
- Excessive vision expectations after surgery or too sensitive, nervous, depressed or picky
- Unsupervised or unable to comply with scheduled visits
- The contralateral eye was judged to lose visual function
- Other situations where the researcher judges that the patient is not suitable for inclusion
Sites / Locations
- Eye & ENT Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multifocal and Extended Depth-of-Focus intraocular lenses
Monofocal intraocular Lenses
Arm Description
Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation
Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation
Outcomes
Primary Outcome Measures
Postoperative UDVA measured with standard visual acuity charts
postoperative uncorrected distance visual acuity(UDVA)
Postoperative UIVA measured with standard visual acuity charts
Postoperative uncorrected intermediate visual acuity(UIVA)
Postoperative UNVA measured with standard visual acuity charts
Postoperative uncorrected near visual acuity(UNVA)
Secondary Outcome Measures
monocular vision measured with standard visual acuity charts
Uncorrected distance visual acuity and best corrected distance visual acuity
monocular vision measured with standard visual acuity charts
Uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity
Diopter measured by Phorometer
Important factor affecting the improvement of postoperative visual function
IOL rotation stability
The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
Wavefront aberration measured with the iTrace (Tracey Technologies, Houston, TX)
total aberration, total low-order aberration, and total high-order aberration
Contrast sensitivity measured by FACT chart
Provide accurate and comprehensive objective basis for the evaluation of visual function of cataract patients
Binocular vision measured with standard visual acuity charts
Uncorrected distance visual acuity, best corrected distance visual acuity, uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity.
The rate of IOL dislocation
Effectiveness evaluation index
Defocus Curve
Drawing Defocus Curve after taking the average of the data collected in each group of patients
Postoperative satisfaction：Chinese version visual function index-12(VF-12-CN)
Questionnaire survey on patients' quality of life
Full Information
NCT ID
NCT04522427
First Posted
August 16, 2020
Last Updated
August 19, 2020
Sponsor
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT04522427
Brief Title
Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery
Official Title
Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Laser Refractive Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single-center, randomized, open, positive product, parallel controlled trial to evaluate the clinical outcomes of presbyopia-correcting intraocular lenses(IOLs) in eyes with previous corneal refractive surgery.
Specific Aim 1 (Primary): To compare the surgical successful rate of Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.
Specific Aim 2 (Secondary): To study the suboptimal surgical outcomes between Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.
Detailed Description
Recently, the demands for myopia correction and corneal refractive laser surgery are rising with the increased prevalence of myopia. Corneal laser refractive surgery includes photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), laser-assisted subepithelial keratomileusis ( LASEK), femtosecond assisted laser in situ keratomileusis (FS-LASIK), and small incision lenticule extraction(SMILE). At present, FS-LASIK and SMILE are the mainstream methods for correcting myopia refractive surgery with advantages of safety, reliability, predictability and stability compared with other types of refractive surgery. Cataract is the most important cause of blindness in my country and even in the world. More than 50% of blind people are caused by cataract. Many patients who have undergone corneal laser refractive surgery may develop presbyopia or cataracts with age. Phacoemulsification and intraocular lens(IOLs) implantation are the main methods for cataract due to lacking effective pharmaceutical treatments. In addition, the patients who use traditional monofocal IOLs without the ability of accommodation may fail to get rid of glasses. Therefore, a solution that can provide both distance vision and near vision is needed to the presbyopia or cataracts patients with previous corneal refractive surgery and accustomed to taking glasses off.The application of presbyopic IOL in cataract after corneal refractive surgery become extensive with the IOL technology continuously advancing, including Extended Depth-of-Focus(EDOF) IOL, multifocal IOL(especially trifocal IOL) and so on, which can improve the distance, middle, and near visual acuity conducing to reduce the rate of wearing glasses after cataract surgery.
This project is a single-center, randomized, open, positive product, parallel controlled trial to study the clinical outcomes and applied value of presbyopic IOLs, including EDOF and trifocal IOLs after corneal laser refractive surgery complicated with cataracts, and seek better solutions to enable patients to achieve satisfactory visual quality and refractive results after surgery, culminating in completing patients' demand of taking glasses off.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Presbyopia
Keywords
Post-corneal Refractive Surgery, Presbyopia-correcting IOL, Cataract, Efficiency, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multifocal and Extended Depth-of-Focus intraocular lenses
Arm Type
Experimental
Arm Description
Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation
Arm Title
Monofocal intraocular Lenses
Arm Type
Active Comparator
Arm Description
Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation
Intervention Type
Device
Intervention Name(s)
Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)
Intervention Description
IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF
Intervention Type
Device
Intervention Name(s)
Use Monofocal intraocular lenses(IOLs)
Intervention Description
Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS
Primary Outcome Measure Information:
Title
Postoperative UDVA measured with standard visual acuity charts
Description
postoperative uncorrected distance visual acuity(UDVA)
Time Frame
Measured 3 months after cataract surgery
Title
Postoperative UIVA measured with standard visual acuity charts
Description
Postoperative uncorrected intermediate visual acuity(UIVA)
Time Frame
Measured 3 months after cataract surgery
Title
Postoperative UNVA measured with standard visual acuity charts
Description
Postoperative uncorrected near visual acuity(UNVA)
Time Frame
Measured 3 months after cataract surgery
Secondary Outcome Measure Information:
Title
monocular vision measured with standard visual acuity charts
Description
Uncorrected distance visual acuity and best corrected distance visual acuity
Time Frame
Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
Title
monocular vision measured with standard visual acuity charts
Description
Uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity
Time Frame
Measured 1 month, 3 months, and 6 months after cataract surgery
Title
Diopter measured by Phorometer
Description
Important factor affecting the improvement of postoperative visual function
Time Frame
Measured 1 month, 3 months, and 6 months after cataract surgery
Title
IOL rotation stability
Description
The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
Time Frame
Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
Title
Wavefront aberration measured with the iTrace (Tracey Technologies, Houston, TX)
Description
total aberration, total low-order aberration, and total high-order aberration
Time Frame
Measured 1 month, 3 months, and 6 months after cataract surgery
Title
Contrast sensitivity measured by FACT chart
Description
Provide accurate and comprehensive objective basis for the evaluation of visual function of cataract patients
Time Frame
Measured 6 months after cataract surgery
Title
Binocular vision measured with standard visual acuity charts
Description
Uncorrected distance visual acuity, best corrected distance visual acuity, uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity.
Time Frame
Measured 6 months after cataract surgery
Title
The rate of IOL dislocation
Description
Effectiveness evaluation index
Time Frame
Measured 6 months after cataract surgery
Title
Defocus Curve
Description
Drawing Defocus Curve after taking the average of the data collected in each group of patients
Time Frame
Measured 6 months after cataract surgery
Title
Postoperative satisfaction：Chinese version visual function index-12(VF-12-CN)
Description
Questionnaire survey on patients' quality of life
Time Frame
Measured 6 months after cataract surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The operated eye has ever undergone corneal refractive surgery, including PRK, LASIK, LASEK, FS-LASIK, SMILE and excluding RK
At least one eye suffering from cataract and expected to undergo phacoemulsification and IOL implantation and cataract nuclei rigidity in the operated eye from 1 to 3 degree
Expected to use intraocular lens power in -10.0D~+30.0D
Willing and able to comply with scheduled visits and other study procedures.
The need to decrease the dependence of glasses
Signing an informed consent form
Exclusion Criteria:
Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
The density of corneal endothelial cells is lower than 2000/mm2
The natural diameter of the pupil under the darkroom is less than 3mm or greater than 5.5mm
The Kappa or Alpha angle of the operated eye is greater than 0.5mm, or the Kappa angle is greater than half of the diameter of the central refractive optical zone in the multifocal intraocular lens
Patients with expected best corrected distance visual acuity(BCDVA) less than 0.5 (decimal vision)
Occurrence of irregular corneal astigmatism that affects postoperative vision
Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye
Pregnant, lactation or planning to become pregnant in the near future
Any surgical contraindications
Uncontrolled systemic or ocular disease
Use of any systemic or topical drug known to interfere with visual performance
Other ocular surgery at the time of the cataract extraction
Traumatic cataract or congenital bilateral cataract in the operated eye
Getting used to reading with glasses
High requirements for visual functions in patients' career or daily life
Professional drivers or frequent outdoor workers at night
A medical history of photophobia
Amblyopia
Excessive vision expectations after surgery or too sensitive, nervous, depressed or picky
Unsupervised or unable to comply with scheduled visits
The contralateral eye was judged to lose visual function
Other situations where the researcher judges that the patient is not suitable for inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yinghong Ji, phD
Phone
18917785069
Email
jiyh_eent@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yinghong Ji, phD
Organizational Affiliation
Eye Institute, Eye & ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinghong Ji, phD
Phone
18917785069
Email
jiyh_eent@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery
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