Intraestromal Corneal Ring in Mild Keratoconus

Not Applicable

Completed

• Conditions: Eye Diseases; Ophthalmological Disorder; Cornea; Keratoconus
• Interventions: Device: Intraestromal corneal ring

• Registration Number: NCT03127163
• Lead Sponsor: University of Sao Paulo

Brief Summary

To determine whether the implantation of an intrastromal corneal ring is an effective treatment for a homogeneous group of mild keratoconus patients.

Detailed Description

A group of 65 patients with mild keratoconus were implanted with a Ferrara ring in a single eye. Six months after surgery, the aberrations were measured and the visual function was determined using clinical indices. The aberrations, especially comatic aberration (coma), were measured independently.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01-10
• Primary Completion: 2016-01-10
• Study Completion: 2017-01-10
• Status Verified: 2017-04
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-23
• Last Update Submitted: 2017-04-23
• Study First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Investigators used the Amsler-Krumeich classification and included only patients classified as grade I or II.

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Exclusion Criteria

• Investigators excluded patients with central corneal scarring, with other eye disorders, or with previous ocular surgery. We also excluded patients with a history of herpes infection, keratitis, corneal dystrophies, diagnoses of autoimmune diseases, systemic connective tissue disorders, or acute keratoconus.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mild Keratoconus	Intraestromal corneal ring	A group of 65 patients with keratoconus who were implanted with an intrastromal corneal ring; the group was composed of 40 males (61.50%) and 25 females (38.50%), with a mean age of 27.88 ± 7.38 years (range, 17-47 years). The patients were fully informed about the study and signed a consent form previously approved by the ethics committee of our institution. We used the Amsler-Krumeich classification and included only patients classified as grade I or II. The investigators performed the intraestromal corneal ring surgery in the selected group.

Primary Outcome Measures

Name	Time	Method
Aberrations were measured and the visual function was determined using clinical indices.	3 months after surgery	Wave front data

Secondary Outcome Measures

Name	Time	Method
UCVA	3 months after surgery	Uncorrected visual acuity
BCVA	3 months after surgery	Best corrected visual acuity

Trial Locations

Locations (1)

Hospital das Clínicas; 🇧🇷 Sao Paulo, SP, Brazil