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

NCT05596838 | Active Not Recruiting

• 1 other identifier: STAK
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Intracorneal Ring; Keratoconus; Laser

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.

  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.

  1 year

Study Arms (1)

Patient operated at Somain institute with the placement of intracorneal rings

patient operated in the last 10 years on one or both eyes

Procedure: Intracorneal rings placement

Interventions

Intracorneal rings placement PROCEDURE

Intracorneal rings placement in keratoconus using laser

Patient operated at Somain institute with the placement of intracorneal rings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient operated at Somain institue with the placement f intra-corneal rings using laser

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Institut Ophtalmique de Somain

Somain, 59490, France

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: January 20, 2023
• Primary Completion: March 1, 2024
• Study Completion: January 1, 2026
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

FR (1)