NCT05261685

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

February 21, 2022

Last Update Submit

July 8, 2022

Conditions

Moderate Hyperopia

Keywords

Single-step PRKStreamLight PRKHyperopiaPhotorefractive keratectomy

Outcome Measures

Primary Outcomes (2)

  • Visual acuity

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

    12 months

  • Cycloplegic refraction

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

    12 months

Secondary Outcomes (2)

  • Keratometry and corneal asphericity

    12 months

  • Post-PRK haze

    12 months

Study Arms (1)

Hyperopic patients planned to undergo single-step transepithelial PRK

EXPERIMENTAL

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

Procedure: Single-step transepithelial PRK

Interventions

Single-step transepithelial PRKPROCEDURE

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.

Hyperopic patients planned to undergo single-step transepithelial PRK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TIBA eye center

Asyut, 71516, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 27027624BACKGROUND

  • 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.

    PMID: 36855211DERIVED

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Mahmoud Abdel-Radi

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

December 1, 2019

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

July 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)