Scleral Fixation for Intraocular Lens-Bag Dislocation

Pseudoexfoliation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06423079
• Other study ID #: Siep_001
• Status: Completed
• Start date: May 10, 2017
• Est. completion date: May 10, 2022

Study information

• Verified date: May 2024
• Source: University of Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2019
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Pseudoexfoliation Syndrome

Intervention

Procedure:
• Siepser knots
Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation

Locations

Country	Name	City	State
Italy	University of Naples Federico II	NAples

Sponsors (1)

Lead Sponsor	Collaborator
University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity	to evaluate the best corrected visual acuity after the surgery	1 year
Secondary	Endothelial cells count	to evaluate the Endothelial cells count after the surgery	1 year