A Novel Approach to Lens Subluxation

NCT ID: NCT06773273

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2024-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Subluxation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This retrospective interventional randomized study included 15 eyes of 15 patients; six of them were due to pseudo exfoliation, five of them were males while the other nine cases were due to hereditary lens subluxation eight of them were females.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture

CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation

Group Type OTHER

CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture

Intervention Type PROCEDURE

CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation

Interventions

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CapsuLaser-Assisted Capsulorhexis and Flanged Prolene Suture

CapsuLaser-Assisted Capsulorhexis and Flanged 6-0 Prolene Suture for Cionni Ring Scleral Fixation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Lens subluxation with clear corneal media.

Exclusion Criteria

* Associated macular lesions.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AHMED SAMIR, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

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Maghrabi Eye Hospitals

Jeddah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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Maghrabi eye hospitals

Identifier Type: OTHER

Identifier Source: secondary_id

MEH-IRB# 355 -5-January -2025

Identifier Type: -

Identifier Source: org_study_id

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