Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser

Active, not recruiting

• Conditions: Intracorneal Ring; Laser; Keratoconus
• Interventions: Procedure: Intracorneal rings placement

• Registration Number: NCT05596838
• Lead Sponsor: Elsan

Brief Summary

Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses.

Surgeries such as crosslinking and intracorneal rings placement are alternatives to corneal transplantation with the expected effects: stabilization of the disease for corneal collagen crosslinking and visual rehabilitation by the placement of intracorneal rings.

The main objective of this study is to evaluate visual benefit1 year after placement of intracorneal rings using laser in keratoconus

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Study Start: 2023-01-20
• Status Verified: 2024-03
• Primary Completion: 2024-03-01
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patient having received the information notice/non-objection
• Adult man or woman (over 18)
• Failure of a lens fitting adaptation
• Patient with a diagnosis of keratoconus
• Patient operated at Somain institute with the placement of intra-corneal rings

Exclusion Criteria

• Minor
• Post-lasik ectasia
• Iatrogenic Keratoconus
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient operated at Somain institute with the placement of intracorneal rings	Intracorneal rings placement	patient operated in the last 10 years on one or both eyes

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.	1 year	Evolution of the best corrected visual acuity (BCVA) 1 year after the installation of intra-corneal rings compared to the preoperative value. Visual acuity will be expressed in logMAR.

Trial Locations

Locations (1)

Institut Ophtalmique de Somain; 🇫🇷 Somain, France