Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions (PTK x CE)

This study has been completed.
Sponsor:
Information provided by:
Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT01251692
First received: November 30, 2010
Last updated: December 1, 2010
Last verified: November 2010
  Purpose

To determine the ten-year visual results and outcome of excimer laser phototherapeutic keratectomy (PTK) for recurrent corneal erosions.


Condition Intervention Phase
Recurrent Corneal Erosions
Procedure: Surgery
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ten-year Results of Phototherapeutic Keratectomy on Recurrent Corneal Erosions

Further study details as provided by Instituto de Olhos de Goiania:

Enrollment: 26
Study Start Date: January 1996
Study Completion Date: January 2010
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
A retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to conventional therapy. Data regarding the preoperative and postoperative best-corrected visual acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. The mean duration of symptoms prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years (range, 10 to 14 years).
Procedure: Surgery
The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser.

Detailed Description:

A retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to conventional therapy. Data regarding the preoperative and postoperative best-corrected visual acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and complications arising from the laser treatment were analyzed. The mean duration of symptoms prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years (range, 10 to 14 years).

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Recurrent corneal erosions Patients 21 to 50 years old Conventional treatments have failed

Exclusion Criteria:

  • Diabetes
  • Autoimmune diseases
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01251692

Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
Study Chair: Belquiz A Nassaralla Instituto de Olhos de Goiânia
  More Information

No publications provided

Responsible Party: Belquiz Rodrigues do Amaral Nassaralla, Instituto de Olhos de Goiânia
ClinicalTrials.gov Identifier: NCT01251692     History of Changes
Other Study ID Numbers: BQ-1-10-ARVO
Study First Received: November 30, 2010
Last Updated: December 1, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Olhos de Goiania:
Corneal erosions
PTK

ClinicalTrials.gov processed this record on July 26, 2014