Intraestromal Corneal Ring in Mild Keratoconus

University of Sao Paulo

Status: Completed

Conditions: Keratoconus; Ophthalmological Disorder; Eye Diseases; Cornea

Treatments: Device: Intraestromal corneal ring

Study type: Interventional

Funder types: Other

Identifiers

NCT03127163

0591/11

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 17 to 47 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Mild Keratoconus

Other group

Description:

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.

Treatment:

Device: Intraestromal corneal ring