Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)

NCT ID: NCT02008253

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Ectasia

Keywords

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INTRASTROMAL CORNEAL RING ASTIGMATISM

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

INTRASTROMAL CORNEAL RING SEGMENT

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Diabetes
* Autoimmune diseases
Minimum Eligible Age

19 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Olhos de Goiania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larissa Rossana S Stival

Role: STUDY_CHAIR

Instituto de Olhos de Goiânia

Locations

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Instituto de Olhos de Goiânia

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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BQ-1-14 - ARVO

Identifier Type: -

Identifier Source: org_study_id