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

Sponsor

Elsan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05596838

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intracorneal Ring Keratoconus Laser	Procedure: Intracorneal rings placement

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jan 10, 2023

Anticipated Primary Completion Date :

Jan 10, 2024

Anticipated Study Completion Date :

Jan 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
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 Intracorneal rings placement in keratoconus using laser

Arm

Intervention/Treatment

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

Intracorneal rings placement in keratoconus using laser

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Ophtalmique de Somain	Somain		France	59490

Sponsors and Collaborators

Elsan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elsan

ClinicalTrials.gov Identifier:

NCT05596838

Other Study ID Numbers:

STAK

First Posted:

Oct 27, 2022

Last Update Posted:

Dec 28, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Keratoconus

Study Results

No Results Posted as of Dec 28, 2022