Intrastromal Corneal Ring for High Astigmatism on Postkeratoplasty (Anel)
Primary Purpose
Astigmatism
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
INTRASTROMAL CORNEAL RING SEGMENT
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism focused on measuring INTRASTROMAL CORNEAL RING, ASTIGMATISM, POSTKERATOPLASTY, EYES, To evaluate the clinical outcomes of ICRS implantation to correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK)
Eligibility Criteria
Inclusion Criteria:
- > 5 diopters of postkeratoplasty astigmatism
- Patients 21 to 50 years old
- Conventional treatments have failed
Exclusion Criteria:
- Diabetes
- Autoimmune diseases
Sites / Locations
- Instituto de Olhos de Goiânia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INTRASTROMAL CORNEAL RING SEGMENT
Arm Description
Eighteen eyes of 18 patients, 8 men and 10 women, with high levels (> 5 diopters [D]) of postkeratoplasty astigmatism were studied in a nonrandomized, retrospective, observational case series. PK was performed to treat keratoconus in 15 patients, corneal scar after trauma in 2 patients, and Fuchs endothelial dystrophy in 1 patient.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01018797
First Posted
November 21, 2009
Last Updated
November 23, 2009
Sponsor
Instituto de Olhos de Goiania
1. Study Identification
Unique Protocol Identification Number
NCT01018797
Brief Title
Intrastromal Corneal Ring for High Astigmatism on Postkeratoplasty
Acronym
Anel
Official Title
Intrastromal Corneal Ring Segment Implantation for High Astigmatism on Postkeratoplasty Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto de Olhos de Goiania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the clinical outcomes of Intrastromal Corneal Ring Segment (ICRS) implantation to correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK).
Detailed Description
Eighteen eyes of 18 patients, 8 men and 10 women, with high levels (> 5 diopters [D]) of postkeratoplasty astigmatism were studied in a nonrandomized, retrospective, observational case series. Mean age at the time of ICRS implantation was 38 years, range 22 to 49 years. PK was performed to treat keratoconus in 15 patients, corneal scar after trauma in 2 patients, and Fuchs endothelial dystrophy in 1 patient. All patients were spectacle and contact lens intolerant. There was no active corneal disease or problem apart from high astigmatism.
Minimum time of ICRS implantation was 2 years after PK and at least 6 months after sutures removal.
Preoperative examinations included personal medical ocular history, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, keratometry, intraocular pressure (IOP) measurement by applanation tonometry, corneal astigmatism, surface regularity index, surface asymmetry index, tonometry, slit-lamp biomicroscopy, specular microscopy, and fundus examination.
Main outcome measures included UCVA, BSCVA, refraction, keratometry and computerized analysis of corneal topography.
All surgeries were performed by the same surgeon (BAN) at the Goiania Eye Institute, between July 2007 and January 2009. Corneal tunnels were created by means of mechanical dissection in all eyes. Intrastromal corneal ring segments implantation was indicated because of the existence of reduced best spectacle-corrected visual acuity (BSCVA) or contact lens intolerance. Intracorneal ring segments implantations were performed by the same surgeon following the same protocol. All eyes were implanted with the Cornealring (Visiontech Medical Optics, Belo Horizonte, MG, Brazil). Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).
The procedure, its goals, and possible complications were explained and all patients signed an informed consent. The amount and axis of astigmatism to be corrected by ICRS was based on manifest refraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
INTRASTROMAL CORNEAL RING, ASTIGMATISM, POSTKERATOPLASTY, EYES, To evaluate the clinical outcomes of ICRS implantation to correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INTRASTROMAL CORNEAL RING SEGMENT
Arm Type
Experimental
Arm Description
Eighteen eyes of 18 patients, 8 men and 10 women, with high levels (> 5 diopters [D]) of postkeratoplasty astigmatism were studied in a nonrandomized, retrospective, observational case series. PK was performed to treat keratoconus in 15 patients, corneal scar after trauma in 2 patients, and Fuchs endothelial dystrophy in 1 patient.
Intervention Type
Procedure
Intervention Name(s)
INTRASTROMAL CORNEAL RING SEGMENT
Intervention Description
Corneal tunnels were created by means of mechanical dissection in all eyes. Intrastromal corneal ring segments implantation was indicated because of the existence of reduced best spectacle-corrected visual acuity (BSCVA) or contact lens intolerance.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 5 diopters of postkeratoplasty astigmatism
Patients 21 to 50 years old
Conventional treatments have failed
Exclusion Criteria:
Diabetes
Autoimmune diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belquiz A Nassaralla
Organizational Affiliation
Instituto de Olhos de Goiânia
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Olhos de Goiânia
City
Goiânia
State/Province
GO
ZIP/Postal Code
74120-050
Country
Brazil
12. IPD Sharing Statement
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Intrastromal Corneal Ring for High Astigmatism on Postkeratoplasty
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