- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01251692
Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions (PTK x CE)
December 1, 2010 updated by: Instituto de Olhos de Goiania
Ten-year Results of Phototherapeutic Keratectomy on Recurrent Corneal Erosions
To determine the ten-year visual results and outcome of excimer laser phototherapeutic keratectomy (PTK) for recurrent corneal erosions.
Study Overview
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
Enrollment (Actual)
26
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Recurrent corneal erosions Patients 21 to 50 years old Conventional treatments have failed
Exclusion Criteria:
- Diabetes
- Autoimmune diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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).
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1996
Primary Completion (ACTUAL)
January 1, 2000
Study Completion (ACTUAL)
January 1, 2010
Study Registration Dates
First Submitted
November 30, 2010
First Submitted That Met QC Criteria
December 1, 2010
First Posted (ESTIMATE)
December 2, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
December 2, 2010
Last Update Submitted That Met QC Criteria
December 1, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BQ-1-10-ARVO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.