NCT03569423

Brief Summary

PURPOSE: The aim of the study is to compare visual acuity means, refractive results, safety, and efficacy of TPRK with AAPRK as primary outcomes and surgical time, pain scores, haze levels, and healing time as secondary outcomes. SETTING: Security Forces Hospital, Ophthalmology Department, Riyadh, Kingdom of Saudi Arabia. DESIGN: Prospective, consecutive, nonrandomized case-control comparative study. . METHODS: A total of 200 eyes of 100 patients were included. One hundred eyes underwent TPRK in the right eye (study group) and 100 eyes underwent AAPRK in the left eye (control group). Ablations performed with the Schwind Amaris, 750S. Clinical outcomes were compared Paired student's t-tests and Mann-Whitney tests were used for statistical analysis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
2 countries

2 active sites

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

February 15, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

April 27, 2018

Last Update Submit

June 22, 2018

Conditions

Refractive SurgeryMyopia

Outcome Measures

Primary Outcomes (1)

  • Visual acuity means

    visual acuity means in decimal value from minimum 0.1 to maximum 1.2.

    6 months

Secondary Outcomes (4)

  • Surgical time

    6 months

  • Pain scores

    6 months

  • Haze levels

    6 months

  • Complete epithelial healing time

    6 months

Study Arms (2)

Transepithelial PRK

EXPERIMENTAL

Transepithelial photorefractive keratectomy was done in 100 right eyes of 100 patients included in the study.

Procedure: Transepithelial photorefractive keratectomyProcedure: Alcohol assisted photorefractive keratectomy

Alcohol assisted PRK

ACTIVE COMPARATOR

Alcohol assisted photorefractive keratectomy was done in 100 left eyes of the same 100 patients included in the study.

Procedure: Transepithelial photorefractive keratectomyProcedure: Alcohol assisted photorefractive keratectomy

Interventions

Transepithelial photorefractive keratectomyPROCEDURE

ablations were performed with the Schwind Amaris excimer LASER 750S. Paired student's t-tests and Mann-Whitney tests were used for statistical analysis.

Also known as: TPRK
Alcohol assisted PRKTransepithelial PRK
Alcohol assisted photorefractive keratectomyPROCEDURE

ablations were performed with the Schwind Amaris excimer LASER 750S. Paired student's t-tests and Mann-Whitney tests were used for statistical analysis.

Also known as: APRK
Alcohol assisted PRKTransepithelial PRK

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age over 18 years
  • Primary myopia or compound myopic astigmatism
  • Preoperative manifest refraction spherical equivalent (MRSE) within the range of -1.50 to -7 D
  • Stable refraction for at least 1 year before the surgery
  • Contact lens discontinuation for at least 3 weeks
  • Estimated stromal corneal bed thickness of \>330 μm at the thinnest location.

You may not qualify if:

  • Previous ocular surgery
  • Active ocular diseases
  • Corneal dystrophy
  • Retinal disease
  • Glaucoma
  • Dry eye
  • History of severe eye trauma
  • Irregular astigmatism or suspected keratoconus on corneal topography
  • Systemic disease that could affect corneal wound healing such as collagen diseases, diabetes mellitus, and pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shaaban A Elwan

Al Minyā, Egypt

Location

Security forces hospital

Riyadh, Central, 11481-3643, Saudi Arabia

Location

Related Publications (8)

  • Leaming DV. Practice styles and preferences of ASCRS members--2003 survey. J Cataract Refract Surg. 2004 Apr;30(4):892-900. doi: 10.1016/j.jcrs.2004.02.064.

    PMID: 15093657RESULT

  • Blake CR, Cervantes-Castaneda RA, Macias-Rodriguez Y, Anzoulatous G, Anderson R, Chayet AS. Comparison of postoperative pain in patients following photorefractive keratectomy versus advanced surface ablation. J Cataract Refract Surg. 2005 Jul;31(7):1314-9. doi: 10.1016/j.jcrs.2004.11.046.

    PMID: 16105600RESULT

  • Abad JC, An B, Power WJ, Foster CS, Azar DT, Talamo JH. A prospective evaluation of alcohol-assisted versus mechanical epithelial removal before photorefractive keratectomy. Ophthalmology. 1997 Oct;104(10):1566-74; discussion 1574-5. doi: 10.1016/s0161-6420(97)30095-5.

    PMID: 9331192RESULT

  • Camellin M. Laser epithelial keratomileusis for myopia. J Refract Surg. 2003 Nov-Dec;19(6):666-70. doi: 10.3928/1081-597X-20031101-09.

    PMID: 14640432RESULT

  • Carr JD, Patel R, Hersh PS. Management of late corneal haze following photorefractive keratectomy. J Refract Surg. 1995 May-Jun;11(3 Suppl):S309-13. doi: 10.3928/1081-597X-19950502-25.

    PMID: 7553113RESULT

  • Sin S, Simpson TL. The repeatability of corneal and corneal epithelial thickness measurements using optical coherence tomography. Optom Vis Sci. 2006 Jun;83(6):360-5. doi: 10.1097/01.opx.0000221388.26031.23.

    PMID: 16772894RESULT

  • Fadlallah A, Fahed D, Khalil K, Dunia I, Menassa J, El Rami H, Chlela E, Fahed S. Transepithelial photorefractive keratectomy: clinical results. J Cataract Refract Surg. 2011 Oct;37(10):1852-7. doi: 10.1016/j.jcrs.2011.04.029. Epub 2011 Aug 15.

    PMID: 21840678RESULT

  • Bakhsh AM, Elwan SAM, Chaudhry AA, El-Atris TM, Al-Howish TM. Comparison between Transepithelial Photorefractive Keratectomy versus Alcohol-Assisted Photorefractive Keratectomy in Correction of Myopia and Myopic Astigmatism. J Ophthalmol. 2018 Nov 12;2018:5376235. doi: 10.1155/2018/5376235. eCollection 2018.

    PMID: 30538854DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Shaaban A Elwan, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, consecutive, nonrandomized case-control comparative study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of ophthalmology

Study Record Dates

First Submitted

April 27, 2018

First Posted

June 26, 2018

Study Start

February 15, 2017

Primary Completion

April 15, 2018

Study Completion

April 25, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)EG(1)