NCT06110286

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 26, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 26, 2023

Last Update Submit

October 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Corneal high order aberrations measured before and after the intervention by corneal topography machine

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

    1 monthe after surgery

Study Arms (2)

Mechanical photorefractive keratectomy

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

Other: Photorefractive keratectomy

Stream light trans-PRK

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

Other: Photorefractive keratectomy

Interventions

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

Mechanical photorefractive keratectomyStream light trans-PRK

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Myopic patients with spherical equivalent not more than -6D who will present to refractive surgery Centre in Assiut and seeking for refractive surgery to get rid of their glasses and fulfilling the inclusion and exclusion criteria

You may qualify if:

  • 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.

You may not qualify if:

  • Previous ocular surgery
  • Concurrent ocular pathology; corneal scar, corneal dystrophy
  • Systemic disease; Uncontrolled diabetes, collagen disease
  • Post-operative complications; sub-epithelial haze.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, Assiut University, 71515, Egypt

RECRUITING

MeSH Terms

Interventions

Photorefractive Keratectomy

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Central Study Contacts

Esraa R Mokhtar, master

CONTACT

Khaled A Mohamed, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 26, 2023

First Posted

October 31, 2023

Study Start

November 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations