Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)

Sponsor

Instituto de Olhos de Goiania (Other)

Overall Status

Completed

CT.gov ID

NCT02008253

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ectasia	Procedure: INTRASTROMAL CORNEAL RING SEGMENT

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 Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 48 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Diabetes
Autoimmune diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Olhos de Goiânia	Goiânia	Goias	Brazil	74120-050

Sponsors and Collaborators

Instituto de Olhos de Goiania

Investigators

Study Chair: Larissa Rossana S Stival, Instituto de Olhos de Goiânia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Olhos de Goiania

ClinicalTrials.gov Identifier:

NCT02008253

Other Study ID Numbers:

BQ-1-14 - ARVO

First Posted:

Dec 11, 2013

Last Update Posted:

Dec 11, 2013

Last Verified:

Dec 1, 2013

Keywords provided by Instituto de Olhos de Goiania

INTRASTROMAL CORNEAL RING

ASTIGMATISM

Additional relevant MeSH terms:

Dilatation, Pathologic

Study Results

No Results Posted as of Dec 11, 2013