Intraestromal Corneal Ring in Mild Keratoconus

Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus

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

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Keratoconus; Cornea; Ophthalmological Disorder
• Intervention / Treatment: Device: Intraestromal corneal ring

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • Hospital das Clínicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 47 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aberrations were measured and the visual function was determined using clinical indices.	Wave front data	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UCVA	Uncorrected visual acuity	3 months after surgery
BCVA	Best corrected visual acuity	3 months after surgery

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Mário Lima, PhD, São Paulo University investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2015
• Primary Completion (Actual): January 10, 2016
• Study Completion (Actual): January 10, 2017

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 23, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 23, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Corneal Diseases; Eye Diseases; Keratoconus
• Other Study ID Numbers: 0591/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No