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Completed

NCT Number: NCT03127163

Intraestromal Corneal Ring in Mild Keratoconus

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

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Key information

Conditions

Cornea Corneal Diseases Eye Diseases Keratoconus Ophthalmological Disorder

Age range

17 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Intraestromal corneal ring

Device

The patients underwent surgery to implant the intrastromal corneal ring (Ferrara Ophthalmics, Belo Horizonte, Brazil) using a manual technique. The procedures were performed by a single surgeon with extensive training in corneal surgery. All patients received the same ring, and the number (1 or 2 segments), thickness, and arc size were calculated using the nomogram provided by the manufacturer.

Other names: Ferrara ring

Primary outcomes

  1. Aberrations were measured and the visual function was determined using clinical indices.

    Time frame: 3 months after surgery

    Wave front data

Secondary outcomes

  1. UCVA

    Time frame: 3 months after surgery

    Uncorrected visual acuity

  2. BCVA

    Time frame: 3 months after surgery

    Best corrected visual acuity

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 25, 2017
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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