Intraestromal Corneal Ring in Mild Keratoconus

NCT03127163 | Completed

• 1 other identifier: 0591/11
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cornea; Eye Diseases; Keratoconus; Ophthalmological Disorder

Outcome Measures

Primary Outcomes (1)

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

  Wave front data

  3 months after surgery

Secondary Outcomes (2)

• UCVA

  3 months after surgery

• BCVA

  3 months after surgery

Study Arms (1)

Mild Keratoconus

OTHER

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.

Device: Intraestromal corneal ring

Interventions

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.

Also known as: Ferrara ring

Mild Keratoconus

Eligibility Criteria

• Age: 17 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Corneal Diseases; Eye Diseases; Keratoconus

Study Officials

• Mário Lima, PhD

  São Paulo University investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Intraestromal corneal ring

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 25, 2017
• Study Start: January 10, 2015
• Primary Completion: January 10, 2016
• Study Completion: January 10, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)