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OpenTrials
Completed

NCT Number: NCT06423079

Scleral Fixation for Intraocular Lens-Bag Dislocation

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.

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Key information

Conditions

Pseudoexfoliation Syndrome Exfoliation Syndrome Eye Diseases Iris Diseases Uveal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples Federico II

Naples, 80131, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Siepser knots

Procedure

Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation

Primary outcomes

  1. Best corrected visual acuity

    Time frame: 1 year

    to evaluate the best corrected visual acuity after the surgery

Secondary outcomes

  1. Endothelial cells count

    Time frame: 1 year

    to evaluate the Endothelial cells count after the surgery

Sponsors and collaborators

Lead sponsor

University of Naples

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
May 21, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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