Back to resultsIntraestromal Corneal Ring in Mild Keratoconus
Primary Purpose
Cornea, Eye Diseases, Keratoconus
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intraestromal corneal ring
Sponsored by
About this trial
This is an interventional treatment trial for Cornea
Eligibility Criteria
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.
Sites / Locations
- Hospital das Clínicas
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mild Keratoconus
Arm 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.
Outcomes
Primary Outcome Measures
Aberrations were measured and the visual function was determined using clinical indices.
Wave front data
Secondary Outcome Measures
UCVA
Uncorrected visual acuity
BCVA
Best corrected visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03127163
Brief Title
Intraestromal Corneal Ring in Mild Keratoconus
Official Title
Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 10, 2015 (Actual)
Primary Completion Date
January 10, 2016 (Actual)
Study Completion Date
January 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea, Eye Diseases, Keratoconus, Ophthalmological Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intraestromal corneal ring
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild Keratoconus
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Intraestromal corneal ring
Other Intervention Name(s)
Ferrara ring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aberrations were measured and the visual function was determined using clinical indices.
Description
Wave front data
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
UCVA
Description
Uncorrected visual acuity
Time Frame
3 months after surgery
Title
BCVA
Description
Best corrected visual acuity
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mário Lima, PhD
Organizational Affiliation
São Paulo University investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraestromal Corneal Ring in Mild Keratoconus
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