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Single-step Transepithelial PRK for Hyperopia

Primary Purpose

Moderate Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Single-step transepithelial PRK
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Hyperopia focused on measuring Single-step PRK, StreamLight PRK, Hyperopia, Photorefractive keratectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • TIBA eye center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperopic patients planned to undergo single-step transepithelial PRK

Arm Description

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

Outcomes

Primary Outcome Measures

Visual acuity
Uncorrected and corrected distance visual acuity (UDVA,CDVA) measurement using logMAR distant charts.
Cycloplegic refraction
Cycloplegic sphere, cylinder and refractive spherical equivalent (SEQ) were measured with auto-keratorefractometer (KR-8900:Topcon, Korea republic)

Secondary Outcome Measures

Keratometry and corneal asphericity
Postoperative keratorefractive changes in mean keratometry (Km) and Q value were recorded using pentacam (Oculus GmbH, Germany)
Post-PRK haze
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.

Full Information

First Posted
February 21, 2022
Last Updated
July 8, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05261685
Brief Title
Single-step Transepithelial PRK for Hyperopia
Official Title
Twelve-Month Outcome of Single-step Transepithelial Photorefractive Keratectomy for Moderate Hyperopia and Hyperopic Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Hyperopia
Keywords
Single-step PRK, StreamLight PRK, Hyperopia, Photorefractive keratectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperopic patients planned to undergo single-step transepithelial PRK
Arm Type
Experimental
Arm Description
Patients with moderate hyperopia or hyperopic astigmatism were planned to undergo transepithelial PRK using the new single-step StreamLight PRK Technology.
Intervention Type
Procedure
Intervention Name(s)
Single-step transepithelial PRK
Intervention Description
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 Outcome Measure Information:
Title
Visual acuity
Description
Uncorrected and corrected distance visual acuity (UDVA,CDVA) measurement using logMAR distant charts.
Time Frame
12 months
Title
Cycloplegic refraction
Description
Cycloplegic sphere, cylinder and refractive spherical equivalent (SEQ) were measured with auto-keratorefractometer (KR-8900:Topcon, Korea republic)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Keratometry and corneal asphericity
Description
Postoperative keratorefractive changes in mean keratometry (Km) and Q value were recorded using pentacam (Oculus GmbH, Germany)
Time Frame
12 months
Title
Post-PRK haze
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Abdel-Radi
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
TIBA eye center
City
Assiut
ZIP/Postal Code
71516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27027624
Citation
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.
Results Reference
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Single-step Transepithelial PRK for Hyperopia

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