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Clinical Trials/NCT05596838
NCT05596838Active, not recruitingNot Applicable

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

Elsan1 site in 1 country150 target enrollmentStarted: January 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Elsan
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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