Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages

December 23, 2010 updated by: Fernandez-Vega Ophthalmological Institute
The purpose of this study is to properly analyse the visual and refractive outcomes of implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of keratoconus.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

219

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with keratoconus (stage I; stage II and stage III,according to the Amsler-Krumeich keratoconus classification) in whom KeraRing ICRS were implanted at the Fernández-Vega Ophthalmological Institute, Oviedo, Spain.

Description

Inclusion Criteria:

  • Patients who had keratoconus
  • Contact lens intolerance and clear cornea.
  • The maximum keratometric reading was less than 60.00 diopters (D)
  • The minimum corneal thickness more than 300 μm.

Exclusion Criteria:

  • Acute or grade IV keratoconus.
  • Previous corneal or intraocular surgery.
  • Cataract, history of glaucoma or retinal detachment, macular degeneration or retinopathy, neuro-ophthalmic diseases, and history of ocular inflammation

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

Cohorts and Interventions

Group / Cohort
keratoconus stage I in whom KeraRing ICRS were implanted
keratoconus stage II in whom KeraRing ICRS were implanted
keratoconus stage III in whom KeraRing ICRS were implanted

Collaborators and Investigators

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

Sponsor

Fernandez-Vega Ophthalmological Institute

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

January 1, 2008

Study Completion

March 1, 2010

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (ESTIMATE)

December 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 27, 2010

Last Update Submitted That Met QC Criteria

December 23, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOFV-1

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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