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Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures

Primary Purpose

Myopia ≤ -6 Diopters or Myopic Astigmatism ≤ -4 Diopters

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 Myopia ≤ -6 Diopters or Myopic Astigmatism ≤ -4 Diopters focused on measuring Photorefractive Keratectomy PRK, Phototherapeutic Keratectomy PTK, Trans-epithelial PRK, Laser Vision Correction LVC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • Inclusion Criteria: Candidates for Laser vision correction (LVC) with

    1. Myopia up to -6 diopters
    2. Myopic astigmatism up to -4 diopters
    3. Corneal thinnest location ≥ 500 um and a residual stromal bed ≥ 300um.
  • Exclusion criteria

    1. Patients not candidates for LVC.
    2. Hyperopic patients.
    3. Systemic disease that contraindicates LVC.
    4. Intra- or post-operative complications.

Sites / Locations

  • TIBA eye center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients planned to undergo conventional 2 step trans-epithelial PTK-PRK

Patients planned to undergo the new single step trans-epithelial (StreamLight) PRK.

Arm Description

Patients planned to undergo: Epithelial removal using Phototherapeutic Keratectomy PTK as a separate step. Laser Vision Correction using Excimer laser wavefront optimized technology.

Patients planned to undergo: Epithelial removal and Excimer wavefront optimized Laser Vision Correction in a single step using the new StreamLight Technology.

Outcomes

Primary Outcome Measures

Uncorrected distant visual acuity (UDVA)
Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation
Postoperative Refraction (Spherical equivalent)
Measured by Topcon Auto-Keratorefractometer

Secondary Outcome Measures

Epithelial healing duration
Time for the epithelium to heal reported in days after PRK procudre
Postoperative pain
Verbal Rating Scale(a series of words commonly used to describe pain (0: no pain, 1: mild pain, 2: moderate pain, 3: severe pain, 4: disabling pain)
Postoperative Haze
Corneal Haze scoring using slit lamp bio-microscopy according to Fantes scoring system: 0: No haze, completely clear cornea 0.5: Trace haze seen with careful oblique illumination Haze not interfering with visibility of fine iris details Mild obscuration of iris details Moderate obscuration of the iris and lens Complete opacification of the stroma in the area of the scar, anterior chamber is totally obscured

Full Information

First Posted
January 8, 2021
Last Updated
July 19, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04710082
Brief Title
Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures
Official Title
Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (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
Photorefractive keratectomy (PRK) involves mechanical or alcohol assisted debridement of the epithelium that leads to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK). Our study is focusing on comparing the outcomes of the conventional 2 step trans-epithelial PTK-PRK to the new single step trans-epithelial PRK (StreamLight PRK, Alcon lab, TX, USA).
Detailed Description
Photorefractive keratectomy (PRK) is nowadays one of the commonest refractive procedures in laser vision correction (LVC). PRK differs from laser in situ keratomileusis (LASIK) in that it's a flapless procedure involving the removal of corneal epithelium with different techniques including manual removal , alcohol assisted removal or excimer laser assisted removal with phototherapeutic keratectomy (PTK). Mechanical or alcohol assisted debridement of the epithelium may lead to potential basement membrane (BM) injury ,with resultant more significant haze and pain compared to laser assisted epithelial removal known as 2 step trans-epithelial PRK (PTK-PRK). Single step trans-epithelial PRK allows removing the epithelium and stroma in a single step with a single ablation profile. Previous studies paid particular attention for comparing the 2 step PTK-PRK procedure or the new single step PRK procedure to the conventional PRK procedures involving epithelial removal whether manual or alcohol assisted. The aim of this study is to focus on comparing the different outcomes of the new single step Trans-epithelial PRK (StreamLight Technology) versus the routine 2 step PTK-PRK in terms of postoperative vision, epithelial healing, pain scoring and haze evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia ≤ -6 Diopters or Myopic Astigmatism ≤ -4 Diopters
Keywords
Photorefractive Keratectomy PRK, Phototherapeutic Keratectomy PTK, Trans-epithelial PRK, Laser Vision Correction LVC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients planned to undergo conventional 2 step trans-epithelial PTK-PRK
Arm Type
Active Comparator
Arm Description
Patients planned to undergo: Epithelial removal using Phototherapeutic Keratectomy PTK as a separate step. Laser Vision Correction using Excimer laser wavefront optimized technology.
Arm Title
Patients planned to undergo the new single step trans-epithelial (StreamLight) PRK.
Arm Type
Active Comparator
Arm Description
Patients planned to undergo: Epithelial removal and Excimer wavefront optimized Laser Vision Correction in a single step using the new StreamLight Technology.
Intervention Type
Procedure
Intervention Name(s)
Photorefractive keratectomy (PRK)
Intervention Description
Photorefractive keratectomy (PRK) is a surgical procedure used by ophthalmic surgeons to treat patients presented with refractive errors and involves corneal epithelial removal followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism.
Primary Outcome Measure Information:
Title
Uncorrected distant visual acuity (UDVA)
Description
Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation
Time Frame
6 months
Title
Postoperative Refraction (Spherical equivalent)
Description
Measured by Topcon Auto-Keratorefractometer
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Epithelial healing duration
Description
Time for the epithelium to heal reported in days after PRK procudre
Time Frame
2 weeks
Title
Postoperative pain
Description
Verbal Rating Scale(a series of words commonly used to describe pain (0: no pain, 1: mild pain, 2: moderate pain, 3: severe pain, 4: disabling pain)
Time Frame
1 week
Title
Postoperative Haze
Description
Corneal Haze scoring using slit lamp bio-microscopy according to Fantes scoring system: 0: No haze, completely clear cornea 0.5: Trace haze seen with careful oblique illumination Haze not interfering with visibility of fine iris details Mild obscuration of iris details Moderate obscuration of the iris and lens Complete opacification of the stroma in the area of the scar, anterior chamber is totally obscured
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Candidates for Laser vision correction (LVC) with Myopia up to -6 diopters Myopic astigmatism up to -4 diopters Corneal thinnest location ≥ 500 um and a residual stromal bed ≥ 300um. Exclusion criteria Patients not candidates for LVC. Hyperopic patients. Systemic disease that contraindicates LVC. Intra- or post-operative complications.
Facility Information:
Facility Name
TIBA eye center
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26871764
Citation
Kaluzny BJ, Cieslinska I, Mosquera SA, Verma S. Single-Step Transepithelial PRK vs Alcohol-Assisted PRK in Myopia and Compound Myopic Astigmatism Correction. Medicine (Baltimore). 2016 Feb;95(6):e1993. doi: 10.1097/MD.0000000000001993.
Results Reference
background
PubMed Identifier
35864163
Citation
Abdel-Radi M, Shehata M, Mostafa MM, Aly MOM. Transepithelial photorefractive keratectomy: a prospective randomized comparative study between the two-step and the single-step techniques. Eye (Lond). 2023 Jun;37(8):1545-1552. doi: 10.1038/s41433-022-02174-4. Epub 2022 Jul 21.
Results Reference
derived

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Outcomes of a New Trans-epithelial Photorefractive Keratectomy (Streamlight PRK) Compared to Conventional PRK Procedures

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