Corneal Endothelial Assessment After Posterior Chamber Phakic Intraocular Lens Implantation

February 26, 2025 updated by: Noha Mahmoud Abdelhameed, Sohag University
our primary aim of the work to assess the effect of phakic IOL implantation on corneal endothelium. we also used the specular microscope to assess the corneal endothelium

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact Backup

  • Name: Alahmady H Alsamman, Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

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:

  • Our inclusion criteria include: adults 18-35 years of age, myopia ˃ 6 D , anterior chamber depth (ACD) 2.85 mm or greater , an endothelial cell count of ≥ 2000 cells/mm2 and stable refractive history within 0.5 diopter for 1 year.

Exclusion Criteria:

  • anterior chamber depth from endothelium < 2.85 mm, previous or current systemic or eye disease , surgery or trauma, pregnancy and nursing.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: group who implant phakic IOL
specular microscopy examination to assess the endothelial cells before and after phakic IOL implantation
Procedure: phakic IOL implantation
specular microscopy examination to assess endothelial cells before and after phakic IOL implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal endothelial cells assessment
Time Frame: 1 year
specular micrioscopy examination before and after phakic IOL implantation
1 year

Collaborators and Investigators

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

Sponsor

Sohag 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 (Actual)

May 10, 2024

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med--25-1-11MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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