NCT04710082

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

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

June 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

January 8, 2021

Last Update Submit

July 19, 2021

Conditions

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

Keywords

Photorefractive Keratectomy PRKPhototherapeutic Keratectomy PTKTrans-epithelial PRKLaser Vision Correction LVC

Outcome Measures

Primary Outcomes (2)

  • Uncorrected distant visual acuity (UDVA)

    Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation

    6 months

  • Postoperative Refraction (Spherical equivalent)

    Measured by Topcon Auto-Keratorefractometer

    6 months

Secondary Outcomes (3)

  • Epithelial healing duration

    2 weeks

  • Postoperative pain

    1 week

  • Postoperative Haze

    3 months

Study Arms (2)

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

ACTIVE COMPARATOR

Patients planned to undergo: 1. Epithelial removal using Phototherapeutic Keratectomy PTK as a separate step. 2. Laser Vision Correction using Excimer laser wavefront optimized technology.

Procedure: Photorefractive keratectomy (PRK)

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

ACTIVE COMPARATOR

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

Procedure: Photorefractive keratectomy (PRK)

Interventions

Photorefractive keratectomy (PRK)PROCEDURE

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.

Patients planned to undergo conventional 2 step trans-epithelial PTK-PRKPatients planned to undergo the new single step trans-epithelial (StreamLight) PRK.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients not candidates for LVC.
  • Hyperopic patients.
  • Systemic disease that contraindicates LVC.
  • Intra- or post-operative complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TIBA eye center

Asyut, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 26871764BACKGROUND

  • 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.

    PMID: 35864163DERIVED

MeSH Terms

Interventions

Photorefractive Keratectomy

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 14, 2021

Study Start

June 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)