Intraestromal Corneal Ring in Mild Keratoconus

NCT ID: NCT03127163

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-10
• Study Completion Date: 2017-01-10

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.

Conditions

Cornea; Eye Diseases; Keratoconus; Ophthalmological Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild Keratoconus

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.

Group Type: OTHER

Intraestromal corneal ring

Intervention Type: 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.

Interventions

Intraestromal corneal ring

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.

Intervention Type: DEVICE

Other Intervention Names

Ferrara ring

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mário Henrique Camargos de Lima

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mário Lima, PhD

Role: PRINCIPAL_INVESTIGATOR

São Paulo University investigator

Locations

Hospital das Clínicas

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

0591/11

Identifier Type: -

Identifier Source: org_study_id