Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03140046
Collaborator
(none)
20
1
1
12
1.7

Study Details

Study Description

Brief Summary

Irregular astigmatism is one of the most serious and frequent complications of corneal refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is also considered as one of common, serious complications of corneal injuries .

Spectacle correction is usually not useful in the correction of corneal irregular astigmatism. Contact lenses represent a good alternative, but their adaptation and stability are limited by the irregular corneal surface and patient discomfort.

In recent years, advancements in laser technology have offered better tools for dealing with irregular astigmatism with finding new surgical methods to improve corneal regularity for the correction of irregular astigmatism.

Topography-linked excimer laser is a potentially effective technique in the treatment of irregular astigmatism after keratoplasty . In fact, customized ablation was shown to be an effective means of treatment of irregular astigmatism due to different etiologies Such as corneal Injuries , scar , or postoperative.

Some of the theoretical advantages of topography-driven photorefractive keratectomy (PRK) are a better astigmatic correction, the possibility of correcting irregular astigmatism, and a smaller ablation volume compared with standard treatments, resulting in better visual performance.

Aim of the work To evaluate the efficacy, safety, and predictability of topography-guided photorefractive keratectomy (PRK) to improve refractive status of patient with irregular Cornea.

Condition or Disease Intervention/Treatment Phase
  • Procedure: photorefractive keratectomy (PRK)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Corneal Topography

we will do Corneal Topography for every patient before doing photorefractive keratectomy (PRK) and also after it , to measure the change in the quality of vision and measure the change in the quality of vision

Procedure: photorefractive keratectomy (PRK)
The cornea will be ablated while the patient fixating on target light under constant eye-tracking control. The ablations will be made using the "ALLEGRETTO X 500WAVE excimer laser" (WaveLight Laser Technologie AG).
Other Names:
  • PRK
  • Outcome Measures

    Primary Outcome Measures

    1. Visual Acuity [follow up after 1 day, 1 week, 1 month and 3 months]

      The measure of the Visual Acuity and Best Corrected Visual acuity Using the Snellen Chart which give use an idea about visual acuity in Metric scale (e.g. 6\6 , 6\12)

    Secondary Outcome Measures

    1. Refractive State [follow up after 1 day, 1 week, 1 month and 3 months]

      We will measure the Refractive state of the eye by using the Auto refractor which give us an idea about the refractive state in a Diopteric scale ( e.g. -2D , +4 D) .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with irregular corneal astigmatism caused by:

    • Trauma.

    • Non - Central Corneal Scars.

    • Previous corneal surgery.

    • With No other abnormalities in the eye.

    • Patient is willing to enter the study and sign a consent.

    Exclusion Criteria:
    • Patients with central corneal scars.

    • Patients with central haze interfering with visual acuity.

    • Patients with ectasia at corneal graft margins.

    • Patients with irregular astigmatism caused by corneal ectasia or keratoconus.

    • Patients had refractive surgery with ablations leaving a residual corneal thickness less than 250 μm.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Abdelsamee Mohammed, Dr, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03140046
    Other Study ID Numbers:
    • PRK
    First Posted:
    May 4, 2017
    Last Update Posted:
    May 11, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2020