Scleral Fixation for Intraocular Lens-Bag Dislocation

Completed

• Conditions: Pseudoexfoliation Syndrome
• Interventions: Procedure: Siepser knots

• Registration Number: NCT06423079
• Lead Sponsor: University of Naples

Brief Summary

Novel introflective sutures offer a minimally invasive approach for stable fixation of dislocated bag-IOL complexes, preserving visual acuity and reducing corneal complications in patients with pseudoexfoliation syndrome.

Detailed Description

To assess the one-month outcomes of visual performance and positional stability of capsule-fixated intraocular lenses (IOLs) in patients with IOL-Bag complex dislocation. Patients with intraoperative complications or prior posterior capsule Nd-YAG laser were excluded. Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation. Best Corrected Visual acuity (BCVA), endothelial cell counts, and tonometry were assessed at multiple postoperative time points. We also evaluated the mean spherical equivalent (SE), and the residual cylinder and sphere at each follow-up.

Study Timeline

• Study Start: 2017-05-10
• Primary Completion: 2019-05-10
• Study Completion: 2022-05-10
• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex

Exclusion Criteria

• patients who underwent intraoperative complications,
• dislocation in the vitreous chamber of the bag-IOL complex,
• patients who had already undergone posterior capsule Nd-YAG laser

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IOL-Bag Dislocation patients	Siepser knots	Patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex.

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	1 year	to evaluate the best corrected visual acuity after the surgery

Secondary Outcome Measures

Name	Time	Method
Endothelial cells count	1 year	to evaluate the Endothelial cells count after the surgery

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 NAples, Italy