Single-step Transepithelial PRK for Hyperopia

NCT ID: NCT05261685

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-12-15

Brief Summary

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.

Detailed Description

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.

Conditions

Moderate Hyperopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperopic patients planned to undergo single-step transepithelial PRK

Patients with moderate hyperopia or hyperopic astigmatism were planned to undergo transepithelial PRK using the new single-step StreamLight PRK Technology.

Group Type: EXPERIMENTAL

Single-step transepithelial PRK

Intervention Type: 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.

Interventions

Single-step transepithelial PRK

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abdel-Radi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Abdel-Radi

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

TIBA eye center

Asyut, , Egypt

Countries

Egypt

References

Adib-Moghaddam S, Arba-Mosquera S, Walter-Fincke R, Soleyman-Jahi S, Adili-Aghdam F. Transepithelial Photorefractive Keratectomy for Hyperopia: A 12-Month Bicentral Study. J Refract Surg. 2016 Mar;32(3):172-80. doi: 10.3928/1081597X-20160121-01.

Reference Type: BACKGROUND

PMID: 27027624 (View on PubMed)

Abdel-Radi M, Rateb M, Saleh MGA, Aly MOM. Twelve-month outcomes of single-step transepithelial photorefractive keratectomy for moderate hyperopia and hyperopic astigmatism. Eye Vis (Lond). 2023 Mar 1;10(1):7. doi: 10.1186/s40662-023-00327-4.

Reference Type: DERIVED

PMID: 36855211 (View on PubMed)

Other Identifiers

STEPRKH

Identifier Type: -

Identifier Source: org_study_id