Intrastromal Corneal Ring for High Astigmatism on Postkeratoplasty
NCT ID: NCT01018797
Last Updated: 2009-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
18 participants
INTERVENTIONAL
2007-01-31
2009-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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INTRASTROMAL CORNEAL RING SEGMENT
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.
INTRASTROMAL CORNEAL RING SEGMENT
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.
Interventions
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INTRASTROMAL CORNEAL RING SEGMENT
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.
Eligibility Criteria
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Inclusion Criteria
* Patients 21 to 50 years old
* Conventional treatments have failed
Exclusion Criteria
* Autoimmune diseases
21 Years
50 Years
ALL
No
Sponsors
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Instituto de Olhos de Goiania
OTHER
Responsible Party
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Instituto de Olhos de Goiânia
Principal Investigators
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Belquiz A Nassaralla
Role: STUDY_CHAIR
Instituto de Olhos de Goiânia
Locations
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Instituto de Olhos de Goiânia
Goiânia, Goiás, Brazil
Countries
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Other Identifiers
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BQ-1-09-ARVO
Identifier Type: -
Identifier Source: org_study_id