ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01251692
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : December 2, 2010
Sponsor:
Information provided by:
Instituto de Olhos de Goiania

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

Condition or disease Intervention/treatment Phase
Recurrent Corneal Erosions Procedure: Surgery Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ten-year Results of Phototherapeutic Keratectomy on Recurrent Corneal Erosions
Study Start Date : January 1996
Actual Primary Completion Date : January 2000
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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.





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251692


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

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
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: November 2010

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