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Corneal High Order Aberrations After Stream Light and Mechanical Photorefractive Keratectomy

NCT ID: NCT06110286

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-10-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Compare Corneal High Order Aberrations Before and After Stream Light Trans-PRK and Mechanical Photorefractive Keratectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mechanical photorefractive keratectomy

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

Photorefractive keratectomy

Intervention Type OTHER

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

Photorefractive keratectomy

Intervention Type OTHER

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

Interventions

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Photorefractive keratectomy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Khaled Abdelazeem

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university faculty of medicine

Asyut, Assiut University, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Esraa R Mokhtar, master

Role: CONTACT

Phone: 01064021834

Email: [email protected]

Khaled A Mohamed, MD

Role: CONTACT

Phone: 01123869699

Email: [email protected]

Facility Contacts

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Esraa R Mokhtar, Master

Role: primary

Khaled A Mohamed, MD

Role: backup

Other Identifiers

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1799

Identifier Type: -

Identifier Source: org_study_id