A Comparative Study Between Laser and Manual Removal of Corneal Epithelium for Photorefractive Keratectomy

NCT06748599 | Not Yet Recruiting DMC

• 1 other identifier: Laser Vs Manual Keratectomy
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Photorefractive keratectomy (PRK) is a laser eye surgery used to ablate the corneal stroma to correct visual refractive errors . PRK was developed in 1983 by Dr. Steven Trokel and colleagues and first performed in 1987 by Dr. Theo Seiler in Berlin. After receiving approval by the US Food and Drug Administration (FDA) in 1996, PRK was briefly the preferred surgical treatment of ametropia as it provided more predictable and stable results than incisional keratotomy. However, the number of PRK procedures fell in the late 1990s with the growing popularity of laser in situ keratomileusis (LASIK). The study aims to compare the visual and refractive outcomes along with the pain score and patient satisfaction after photorefractive keratectomy in patients who underwent transepithelial or mechanical removal technique

Conditions

Photorefractive Keratectomy

Keywords

removal of corneal epithelium

Outcome Measures

Primary Outcomes (1)

• visual acuity

  best corrected visual acuity (BCVA) will be observed for at least 6 months postoperatively.

  6 month

Study Arms (2)

group A

patients who are assigned for transepithelial PRK

group B

patients who are mechanical PRK using a spatula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in the age group between 18 and 45 years will be included in this study. Subjects selected, which will consist of patients with myopia ( less than - 6 D ) will be divided into 2 groups.

You may qualify if:

• Age : older than 18 years old .
• Gender: Include both males and females.
• Stable refraction for at least 12 months .
• Intraocular pressure less than 21mmHg.
• A period without wearing contact lenses (more than 4 days for soft , more than 2 weeks for rigid contact lenses )
• No history of any Autoimmune disease .
• The refractive error must be one that can be treated by PRK

You may not qualify if:

• \_ patients with any eye disease (significant cataract or unstable glaucoma )
• uncontrolled external disease such as blepharitis, dry eye syndrome, and atopy/allergy.
• patients with Keratoconus and other abnormalities of the cornea such as corneal ectasias , thinning , edema , interstitial or neurotrophic keratitis and extensive vascularisation .
• Patients with active systemic connective tissue disease such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA)
• Ineligibility for Surgery: Exclude patients who are not suitable candidates for surgery .
• Consider excluding pregnant or lactating women .
• Patients unwilling to participate in the study .

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Edwards JD, Bower KS, Sediq DA, Burka JM, Stutzman RD, Vanroekel CR, Kuzmowych CP, Eaddy JB. Effects of lotrafilcon A and omafilcon A bandage contact lenses on visual outcomes after photorefractive keratectomy. J Cataract Refract Surg. 2008 Aug;34(8):1288-94. doi: 10.1016/j.jcrs.2008.04.024.

  PMID: 18655978 BACKGROUND

• Gamaly TO, El Danasoury A, El Maghraby A. A prospective, randomized, contralateral eye comparison of epithelial laser in situ keratomileusis and photorefractive keratectomy in eyes prone to haze. J Refract Surg. 2007 Nov;23(9 Suppl):S1015-20. doi: 10.3928/1081-597X-20071102-07.

  PMID: 18047000 BACKGROUND

• Diakonis VF, Pallikaris A, Kymionis GD, Markomanolakis MM. Alterations in endothelial cell density after photorefractive keratectomy with adjuvant mitomycin. Am J Ophthalmol. 2007 Jul;144(1):99-103. doi: 10.1016/j.ajo.2007.03.039. Epub 2007 May 23.

  PMID: 17509511 BACKGROUND

• Barreto J Jr, Netto MV, Reis A, Nakano M, Alves MR, Bechara SJ. Topography-guided (NIDEK customized aspheric treatment zone) photorefractive keratectomy with mitomycin C after penetrating keratoplasty for keratoconus: case report. J Refract Surg. 2009 Jan;25(1 Suppl):S131-5. doi: 10.3928/1081597X-20090115-10.

  PMID: 19248542 BACKGROUND

• Alio JL, Soria FA, Abbouda A, Pena-Garcia P. Fifteen years follow-up of photorefractive keratectomy up to 10 D of myopia: outcomes and analysis of the refractive regression. Br J Ophthalmol. 2016 May;100(5):626-32. doi: 10.1136/bjophthalmol-2014-306459. Epub 2015 Sep 10.

  PMID: 26359339 BACKGROUND

Central Study Contacts

Sandra Adel Nashed, resident doctor

CONTACT

+201276485120; sandraadelnashed0@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12