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

Primary Purpose

Irregular Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
photorefractive keratectomy (PRK)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irregular Astigmatism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Corneal Topography

Arm Description

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

Outcomes

Primary Outcome Measures

Visual Acuity
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

Refractive State
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) .

Full Information

First Posted
April 26, 2017
Last Updated
May 8, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03140046
Brief Title
Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea
Official Title
Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irregular Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corneal Topography
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
photorefractive keratectomy (PRK)
Other Intervention Name(s)
PRK
Intervention Description
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).
Primary Outcome Measure Information:
Title
Visual Acuity
Description
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)
Time Frame
follow up after 1 day, 1 week, 1 month and 3 months
Secondary Outcome Measure Information:
Title
Refractive State
Description
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) .
Time Frame
follow up after 1 day, 1 week, 1 month and 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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