Intrastromal Corneal Ring for High Astigmatism on Postkeratoplasty (Anel)

This study has been completed.
Sponsor:
Information provided by:
Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT01018797
First received: November 21, 2009
Last updated: November 23, 2009
Last verified: November 2009

November 21, 2009
November 23, 2009
January 2007
July 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01018797 on ClinicalTrials.gov Archive Site
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Intrastromal Corneal Ring for High Astigmatism on Postkeratoplasty
Intrastromal Corneal Ring Segment Implantation for High Astigmatism on Postkeratoplasty Eyes

To evaluate the clinical outcomes of Intrastromal Corneal Ring Segment (ICRS) implantation to correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK).

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Astigmatism
Procedure: 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.
Experimental: 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.
Intervention: Procedure: INTRASTROMAL CORNEAL RING SEGMENT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • > 5 diopters of postkeratoplasty astigmatism
  • Patients 21 to 50 years old
  • Conventional treatments have failed

Exclusion Criteria:

  • Diabetes
  • Autoimmune diseases
Both
21 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01018797
BQ-1-09-ARVO
Yes
BelquizRodrigues do Amaral Nassaralla, Instituto de Olhos de Goiânia
Instituto de Olhos de Goiania
Not Provided
Study Chair: Belquiz A Nassaralla Instituto de Olhos de Goiânia
Instituto de Olhos de Goiania
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP