Scleral Fixation for Intraocular Lens-Bag Dislocation

Complex Intaocular Lens-Bag Fixation With Siepser's Scleral Sliding Knots

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.

Study Overview

• Status: Completed
• Conditions: Pseudoexfoliation Syndrome
• Intervention / Treatment: Procedure: Siepser knots

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Italy
  • NAples, Italy, 80131
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex after cataract surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IOL-Bag Dislocation patients; Patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex.	Procedure: Siepser knots; Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	to evaluate the best corrected visual acuity after the surgery	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial cells count	to evaluate the Endothelial cells count after the surgery	1 year

Collaborators and Investigators

• Sponsor: University of Naples

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Iris Diseases; Exfoliation Syndrome
• Other Study ID Numbers: Siep_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD
• IPD Sharing Time Frame: 5 years
• IPD Sharing Access Criteria: available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No