An interventional study of Intraestromal corneal ring in Cornea, Eye Diseases and Keratoconus, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 17 Years to 47 Years. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
To determine whether the implantation of an intrastromal corneal ring is an effective treatment for a homogeneous group of mild keratoconus patients.
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.
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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
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
Aberrations were measured and the visual function was determined using clinical indices.
Wave front data
Time frame: 3 months after surgery
UCVA
Uncorrected visual acuity
Time frame: 3 months after surgery
BCVA
Best corrected visual acuity
Time frame: 3 months after surgery
Plan to share: No
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo