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

Primary Purpose

Recurrent Corneal Erosions

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Surgery
Sponsored by
Instituto de Olhos de Goiania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Corneal Erosions focused on measuring Corneal erosions, PTK

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes
  • Autoimmune diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm 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).

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2010
    Last Updated
    December 1, 2010
    Sponsor
    Instituto de Olhos de Goiania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01251692
    Brief Title
    Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions
    Acronym
    PTK x CE
    Official Title
    Ten-year Results of Phototherapeutic Keratectomy on Recurrent Corneal Erosions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1996 (undefined)
    Primary Completion Date
    January 2000 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Instituto de Olhos de Goiania

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Corneal Erosions
    Keywords
    Corneal erosions, PTK

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm 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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Recurrent corneal erosions Patients 21 to 50 years old Conventional treatments have failed Exclusion Criteria: Diabetes Autoimmune diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Belquiz A Nassaralla
    Organizational Affiliation
    Instituto de Olhos de Goiânia
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions

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