A Novel Approach to Lens Subluxation

January 8, 2025 updated by: Zagazig University

A Novel Approach to Lens Subluxation: CapsuLaser and Flanged Prolene Suture for Cionni Ring Scleral Fixation

Evaluating new technique for treating patients with subluxation using specific laser type and new 6-0 proline fixating novel technique for the capsular bag

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The management of a subluxated crystalline lens remains a challenge for anterior segment surgeons, largely due to the complex anatomical and functional changes in such cases. Capsulaser is safe and effective tool in creating well centered CCC with consistent 360 degree IOL coverage that ensures better lens stability and effective lens positioning . Combined with using flanged 6-0 Prolene sutures for scleral fixation of Cionni rings, this technique addresses previous limitations by improving intraoperative control.

Study Type

Interventional

Enrollment (Actual)

15

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

  • Saudi Arabia
      • Jedda, Saudi Arabia, 22230
        • Maghrabi Eye Hospitals

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Lens subluxation with clear corneal media.

Exclusion Criteria:

  • Associated macular lesions.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture
CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation
Procedure: CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture
CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases with IOL centration inside the capsular bag
Time Frame: 6 months
the long term stability of the capsular bag
6 months

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: AHMED SAMIR, MD,PhD, Zagazig 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)

May 28, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

December 29, 2024

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEH-IRB# 355 -5-January -2025
  • Maghrabi eye hospitals (Other Identifier: Maghrabi eye hospitals)

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.

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