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Completed

NCT Number: NCT05261685

Single-step Transepithelial PRK for Hyperopia

Hyperopia is one of the commonest refractive errors encountered in ophthalmology practice.

Laser in situ keratomileusis (LASIK) has been widely used to correct hyperopia especially with the advent of femtosecond laser technology allowing larger flap creation suitable for peripheral hyperopic ablations with resultant predictable, effective, and safe refractive outcomes. However, the encountered LASIK flap complications encouraged many surgeons to assess efficiency and safety of surface ablation techniques such as photorefractive keratectomy (PRK) to correct hyperopia.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TIBA eye center

Asyut, 71516, Egypt

About this study

Although the initial refractive results of conventional manual or alcohol assisted PRK for hyperopia were encouraging, the frequently encountered post-PRK complications including undercorrection, overcorrection and regression of the hyperopic error had downgraded the conventional PRK as a preferred procedure for hyperopic correction.

Transepithelial PRK provides an alternative technique to uniformly remove the epithelium using the excimer laser to minimize the potential complications caused by mechanical or alcohol assisted epithelial removal in conventional PRK. Advances in transepithelial PRK technology have allowed refractive surgeons to remove the epithelium followed by stromal laser ablation in a single step instead of performing the procedure in 2 separate steps known as phototherapeutic keratectomy-photorefractive keratectomy (PTK-PRK).

Most of the previous studies paid particular attention to investigate the accuracy and safety of single-step transepithelial PRK in correcting myopia and myopic astigmatism. The aim of the current study is to evaluate the visual and refractive outcomes of the single-step transepithelial PRK procedure in correcting moderate hyperopia and hyperopic astigmatism.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate hyperopia with a hyperopic cycloplegic spherical equivalent between +2 and + 4.5 diopters D.
  • A steep keratometry (Ks) ≤ 46 D.
  • Minimum pachymetry of 500 μm with a calculated residual stromal bed exceeding 350 μm after epithelial and stromal ablation.

Exclusion criteria

  • Patients not candidate for corneal refractive surgery,
  • Steep cornea (Ks > 46 D) with an expected postoperative keratometry > 48 D,
  • Large angle kappa as estimated by Chord mu > 0.25 mm,
  • Hyperopic amblyopia whether unilateral or bilateral with CDVA less than 0.2 . logMAR acuity,
  • Recent contact lens wear, dry eye disease and autoimmune disorders.

Treatment and study plan

Single-step transepithelial PRK

Procedure

Single-step transepithelial Photorefractive keratectomy (PRK) is a corneal refractive surgical procedure utilized to correct myopia, hyperopia and astigmatism where excimer laser is used in a single step to remove the corneal epithelium followed by stromal laser ablation to correct the patient's refractive error.

Primary outcomes

  1. Visual acuity

    Time frame: 12 months

    Uncorrected and corrected distance visual acuity (UDVA,CDVA) measurement using logMAR distant charts.

  2. Cycloplegic refraction

    Time frame: 12 months

    Cycloplegic sphere, cylinder and refractive spherical equivalent (SEQ) were measured with auto-keratorefractometer (KR-8900:Topcon, Korea republic)

Secondary outcomes

  1. Keratometry and corneal asphericity

    Time frame: 12 months

    Postoperative keratorefractive changes in mean keratometry (Km) and Q value were recorded using pentacam (Oculus GmbH, Germany)

  2. Post-PRK haze

    Time frame: 12 months

    Post-PRK haze was evaluated using slit lamp based on Fantes et al. scale:

    Grade 0: No haze, completely clear cornea

    Grade 0.5: Trace haze seen with careful oblique illumination

    Grade 1: Haze not interfering with the visibility of fine details of the iris

    Grade 2: Mild obstruction of iris details

    Grade 3: Moderate obstruction of the iris and lens

    Grade 4: Complete opacification of the stroma in the area of the scar, anterior chamber is totally obscured.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Twelve-Month Outcome of Single-step Transepithelial Photorefractive Keratectomy for Moderate Hyperopia and Hyperopic Astigmatism

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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