Corneal High Order Aberrations After Stream Light and Mechanical Photorefractive Keratectomy

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06110286
Collaborator
(none)
60
1
23
2.6

Study Details

Study Description

Brief Summary

Compare corneal high order aberrations before and after stream light trans-PRK and mechanical photorefractive keratectomy including third order aberrations; Trefoil and coma aberrations and forth order aberrations; spherical aberrations

Condition or Disease Intervention/Treatment Phase
  • Other: Photorefractive keratectomy

Detailed Description

Laser technology has played an important role in promoting the development of ophthalmology, especially corneal refractive surgery.1 Trans-epithelial photorefractive keratectomy (Trans-PRK) has become a highly researched topic in recent years.2 Different epithelial debridement methods with PRK showed favorable results for the surgical treatment of low to moderate myopia3. In mechanical PRK (m-PRK), epithelial debridement is achieved using a blunt spatula, whereas in stream light trans-PRK (t-PRK), there after an excimer laser is used to ablate corneal stroma3. The Stream Light t-PRK is a safe and effective treatment option for the correction of low to moderate myopia.4 Many studies have shown that the corneal asphericity developed significantly after refractive surgeries and introduce higher-order aberrations (HOAs).2 The present study focused on three of the most clinically important HOAs; spherical, coma, and trefoil aberrations, both preoperative and postoperative were recorded from topography over the 6-mm-diameter central corneal zone using Pentacam.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Corneal High Order Aberrations After Stream Light Trans-PRK and Mechanical Photorefractive Keratectomy
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Mechanical photorefractive keratectomy

Laser photorefractive keratecyomy by Ex500 excimer laser after mannual removal of corneal epithelium

Other: Photorefractive keratectomy
Laser keratectomy by EX500 excimer laser after removal of corneal epithelium either mannually or by laser ablation

Stream light trans-PRK

Laser photorefractive keratectomy by Ex500 excimer laser after removal of corneal epithelium by stream-light laser technique

Other: Photorefractive keratectomy
Laser keratectomy by EX500 excimer laser after removal of corneal epithelium either mannually or by laser ablation

Outcome Measures

Primary Outcome Measures

  1. Corneal high order aberrations measured before and after the intervention by corneal topography machine [1 monthe after surgery]

    Third order aberrations; Trefoil and coma aberrations Forth order aberrations; spherical aberrations Trefoil, spherical and coma aberrations

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • • Stable refraction for 1 year (refraction does not exceed 1D more than the last prescribed glasses).

  • Discontinuation of soft contact lens wears at least 1 week before examination.

  • Topography criteria:

  • Corneal thickness equal or more than 470 um

  • Symmetrical bow-tie

  • Back elevation not more than +12

  • Normal Belin\Ambrosio Enhanced ectasia display

  • Spherical equivalent not more than -6D.

Exclusion Criteria:
  • • Previous ocular surgery

  • Concurrent ocular pathology; corneal scar, corneal dystrophy

  • Systemic disease; Uncontrolled diabetes, collagen disease

  • Post-operative complications; sub-epithelial haze.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university faculty of medicine Assiut Assiut University Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khaled Abdelazeem, Associate professor, Assiut University
ClinicalTrials.gov Identifier:
NCT06110286
Other Study ID Numbers:
  • 1799
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Oct 31, 2023