Intraestromal Corneal Ring in Mild Keratoconus

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03127163

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cornea Eye Diseases Keratoconus Ophthalmological Disorder	Device: Intraestromal corneal ring	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Intraestromal corneal ringIntraestromal corneal ring

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus

Actual Study Start Date :

Jan 10, 2015

Actual Primary Completion Date :

Jan 10, 2016

Actual Study Completion Date :

Jan 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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. Other Names: Ferrara ring

Arm

Intervention/Treatment

Other: 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.

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.

Other Names:

Ferrara ring

Outcome Measures

Primary Outcome Measures

Aberrations were measured and the visual function was determined using clinical indices. [3 months after surgery]
Wave front data

Secondary Outcome Measures

UCVA [3 months after surgery]
Uncorrected visual acuity
BCVA [3 months after surgery]
Best corrected visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 47 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas	Sao Paulo	SP	Brazil	05403-000

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator: Mário Lima, PhD, São Paulo University investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mário Henrique Camargos de Lima, PhD, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT03127163

Other Study ID Numbers:

0591/11

First Posted:

Apr 25, 2017

Last Update Posted:

Apr 25, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Eye Diseases

Keratoconus

Study Results

No Results Posted as of Apr 25, 2017