Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery

August 19, 2020 updated by: Eye & ENT Hospital of Fudan University

Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Laser Refractive Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Eye & ENT Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multifocal and Extended Depth-of-Focus intraocular lenses
Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation
Device: Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)
IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF
Active Comparator: Monofocal intraocular Lenses
Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation
Device: Use Monofocal intraocular lenses(IOLs)
Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative UDVA measured with standard visual acuity charts
Time Frame: Measured 3 months after cataract surgery
postoperative uncorrected distance visual acuity(UDVA)
Measured 3 months after cataract surgery
Postoperative UIVA measured with standard visual acuity charts
Time Frame: Measured 3 months after cataract surgery
Postoperative uncorrected intermediate visual acuity(UIVA)
Measured 3 months after cataract surgery
Postoperative UNVA measured with standard visual acuity charts
Time Frame: Measured 3 months after cataract surgery
Postoperative uncorrected near visual acuity(UNVA)
Measured 3 months after cataract surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
monocular vision measured with standard visual acuity charts
Time Frame: Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
Uncorrected distance visual acuity and best corrected distance visual acuity
Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
monocular vision measured with standard visual acuity charts
Time Frame: Measured 1 month, 3 months, and 6 months after cataract surgery
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
Measured 1 month, 3 months, and 6 months after cataract surgery
Diopter measured by Phorometer
Time Frame: Measured 1 month, 3 months, and 6 months after cataract surgery
Important factor affecting the improvement of postoperative visual function
Measured 1 month, 3 months, and 6 months after cataract surgery
IOL rotation stability
Time Frame: Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
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°)
Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
Wavefront aberration measured with the iTrace (Tracey Technologies, Houston, TX)
Time Frame: Measured 1 month, 3 months, and 6 months after cataract surgery
total aberration, total low-order aberration, and total high-order aberration
Measured 1 month, 3 months, and 6 months after cataract surgery
Contrast sensitivity measured by FACT chart
Time Frame: Measured 6 months after cataract surgery
Provide accurate and comprehensive objective basis for the evaluation of visual function of cataract patients
Measured 6 months after cataract surgery
Binocular vision measured with standard visual acuity charts
Time Frame: Measured 6 months after cataract surgery
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.
Measured 6 months after cataract surgery
The rate of IOL dislocation
Time Frame: Measured 6 months after cataract surgery
Effectiveness evaluation index
Measured 6 months after cataract surgery
Defocus Curve
Time Frame: Measured 6 months after cataract surgery
Drawing Defocus Curve after taking the average of the data collected in each group of patients
Measured 6 months after cataract surgery
Postoperative satisfaction：Chinese version visual function index-12(VF-12-CN)
Time Frame: Measured 6 months after cataract surgery
Questionnaire survey on patients' quality of life
Measured 6 months after cataract surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Yinghong Ji, phD, Eye Institute, Eye & ENT Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

August 16, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yinghong Ji

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe