Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)

Completed

• Conditions: Ectasia
• Interventions: Procedure: INTRASTROMAL CORNEAL RING SEGMENT

• Registration Number: NCT02008253
• Lead Sponsor: Instituto de Olhos de Goiania

Brief Summary

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

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 Timeline

• Study Start: 2010-04
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-06
• Last Update Submitted: 2013-12-06
• Study First Posted: 2013-12-11
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

Exclusion Criteria

• Diabetes
• Autoimmune diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
INTRASTROMAL CORNEAL RING SEGMENT	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.

Primary Outcome Measures

Name	Time	Method
Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery	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.

Trial Locations

Locations (1)

Instituto de Olhos de Goiânia; 🇧🇷 Goiânia, Goias, Brazil