Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)

Ectasia Clinical Trial

Official title:

Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008253
• Other study ID #: BQ-1-14 - ARVO
• Status: Completed
• Phase: N/A
• First received: December 1, 2013
• Last updated: December 6, 2013
• Start date: April 2010
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 48 Years

Eligibility

Inclusion Criteria:

• Patients 19 to 48 years old

• Keratoconus (ectasia) on eyes with prior refractive surgery

Exclusion Criteria:

• Diabetes

• Autoimmune diseases

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ectasia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto de Olhos de Goiânia	Goiânia	Goias

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. 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).	Yes