Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)

December 6, 2013 updated by: Instituto de Olhos de Goiania

Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery

To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series. Mean age at the time of ICRS implantation was 30,5 years.

Study Type

Observational

Enrollment (Actual)

29

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

  • Brazil
    • Goias
      • Goiânia, Goias, Brazil, 74120-050
        • Instituto de Olhos de Goiania

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

19 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients residents in Brazil with ectasia after refractive surgery

Description

Inclusion Criteria:

  • Patients 19 to 48 years old
  • Keratoconus (ectasia) on eyes with prior refractive surgery

Exclusion Criteria:

  • Diabetes
  • Autoimmune diseases

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: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
INTRASTROMAL CORNEAL RING SEGMENT
Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series.
Procedure: INTRASTROMAL CORNEAL RING SEGMENT
Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery
Time Frame: Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).
To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery. Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.
Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).

Collaborators and Investigators

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

Sponsor

Instituto de Olhos de Goiania

Investigators

  • Study Chair: Larissa Rossana S Stival, Instituto de Olhos de Goiania

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

April 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 1, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BQ-1-14 - ARVO

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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