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Anterior Versus Posterior Artisan Intraocular Lens Fixation in Aphakic Children With Insufficient Capsular Support.

NCT06396156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-02

No results posted yet for this study

Summary

The Artisan lens (Artisan Aphakic, Ophtec BV) is an iris- claw lens designed for implantation in children with insufficient capsular support. In spite of less surgical manipulations and a relatively shorter operation time, the procedure carries the risk of corneal endothelial cell loss or dis-enclavation, particularly in children. However, most of the studies that studied iris-claw lenses in aphakic children were retrospective evaluated only a single technique; either anterior or retropupillary fixation, or comparable to other techniques of fixation. Thus the aim of this work is to prospectively compare the 2 techniques of iris-claw lens implantation and their effects on central endothelial cell density, the anatomical and visual outcome, as well as the complications' rate.

Conditions

  • Cataracts Infantile
  • Subluxation of Lens
  • Intraocular Lens Complication
  • Corneal Endothelial Cell Loss

Interventions

PROCEDURE

Anterior enclavation

Anterior enclavation of iris-claw lens

PROCEDURE

Posterior enclavation

Posterior enclavation of iris-claw lens

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Hatem Saeed, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06396156 on ClinicalTrials.gov