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NCT05596838 Clinical Trial

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

Keratoconus Clinical Trial

— STAK  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05596838
Other study ID # STAK
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 20, 2023
Est. completion date January 2026

Study information
Verified date March 2024
Source Elsan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date January 2026
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Intracorneal rings placement
Intracorneal rings placement in keratoconus using laser

Locations
Country Name City State
France Institut Ophtalmique de Somain Somain

Sponsors (1)
Lead Sponsor Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT03235856 - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
Withdrawn NCT01789333 - Higher Irradiance in Keratoconus Ectasia N/A
Completed NCT05114928 - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed NCT03647046 - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus N/A
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Recruiting NCT06100939 - Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus Phase 3