Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions

Recurrent Corneal Erosions Clinical Trial

— PTK x CE  

Official title:

Ten-year Results of Phototherapeutic Keratectomy on Recurrent Corneal Erosions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251692
• Other study ID #: BQ-1-10-ARVO
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2010
• Last updated: December 1, 2010
• Start date: January 1996
• Est. completion date: January 2010

Study information

• Verified date: November 2010
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2010
• Est. primary completion date: January 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Diabetes

• Autoimmune diseases

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrent Corneal Erosions

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania