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

March 28, 2024 updated by: Elsan

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Somain, France, 59490
        • Institut Ophtalmique de Somain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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