NCT01251692

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 1996

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
Last Updated

December 2, 2010

Status Verified

November 1, 2010

Enrollment Period

4 years

First QC Date

November 30, 2010

Last Update Submit

December 1, 2010

Conditions

Recurrent Corneal Erosions

Keywords

Corneal erosionsPTK

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

SurgeryPROCEDURE

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.

1

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Diabetes
  • Autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Belquiz A Nassaralla

    Instituto de Olhos de Goiânia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 2, 2010

Study Start

January 1, 1996

Primary Completion

January 1, 2000

Study Completion

January 1, 2010

Last Updated

December 2, 2010

Record last verified: 2010-11