Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study

September 22, 2023 updated by: Akram Fekry Elgazzar, Al-Azhar University
Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations. In addition, pIOLs have been shown to provide better retinal image magnification and higher contrast sensitivity compared to laser in situ keratomileusis, regardless of whether the myopia is low or high.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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 Locations

  • Egypt
      • Damietta, Egypt, 34517
        • Akram Fekry Elgazzar

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • myopia of more than 6 diopter

Exclusion Criteria:

  • unstable refraction
  • unstable refraction

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
Active Comparator: Implantable Collamer Lens (ICL)
Procedure: Implantable Collamer Lens (ICL)
Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations
Active Comparator: Implantable Intraocular Lens (IPCL)
Procedure: Implantable Intraocular Lens (IPCL)
The IPCL offers a distinct economic advantage as the cost of the IPCL implant is only 2. times that of the ICL implant. Moreover, the IPCL can correct higher degrees of myopia, up to -30. D, compared to the maximum correction of -18. D provided by the ICL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UCVA
Time Frame: Baseline
Uncorrected Visual Acuity measured in decimal
Baseline
UCVA
Time Frame: 3 months postoperative
Uncorrected Visual Acuity measured in decimal
3 months postoperative
UCVA
Time Frame: 6 months postoperative
Uncorrected Visual Acuity measured in decimal
6 months postoperative
UCVA
Time Frame: 12 months postoperative
Uncorrected Visual Acuity measured in decimal
12 months postoperative
BCVA
Time Frame: Baseline
Best corrected Visual Acuity measured in decimal
Baseline
BCVA
Time Frame: 3 months postoperative
Best corrected Visual Acuity measured in decimal
3 months postoperative
BCVA
Time Frame: 6 months postoperative
Best corrected Visual Acuity measured in decimal
6 months postoperative
BCVA
Time Frame: 12 months postoperative
Best corrected Visual Acuity measured in decimal
12 months postoperative
Refraction
Time Frame: Baseline
Preoperative refractive error measured in spherical equivalent
Baseline
Refraction
Time Frame: 3 months postoperative
postoperative refractive error measured in spherical equivalent
3 months postoperative
Refraction
Time Frame: 6 months postoperative
postoperative refractive error measured in spherical equivalent
6 months postoperative
Refraction
Time Frame: 12 months postoperative
postoperative refractive error measured in spherical equivalent
12 months postoperative

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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 (Actual)

August 1, 2021

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICL vs IPCL

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.

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