Changes of Higher-Order Aberrations After Different Types of LASIK in Myopia

NCT ID: NCT06860061

Last Updated: 2025-03-05

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-02-28

Brief Summary

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This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).

Detailed Description

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Conditions

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Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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group 1

Conventional Lasik

Group Type ACTIVE_COMPARATOR

Laser refractive surgery

Intervention Type PROCEDURE

This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).

All patients will be subjected to routine comprehensive preoperative examinations including manifest uncorrected distant visual acuity (UCDVA), best corrected distant visual acuity (BCDVA), slit-lamp examination, intraocular pressure, and fundus examination.

Corneal topography and corneal aberrometry will be performed on all patients using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy). The CSO topography system analyzes a total of 6144 corneal points of a corneal area within a circular annulus outlined by an inner radius of 0.33 mm and an outer

group 2

Femto LASIK

Group Type ACTIVE_COMPARATOR

Laser refractive surgery

Intervention Type PROCEDURE

This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).

All patients will be subjected to routine comprehensive preoperative examinations including manifest uncorrected distant visual acuity (UCDVA), best corrected distant visual acuity (BCDVA), slit-lamp examination, intraocular pressure, and fundus examination.

Corneal topography and corneal aberrometry will be performed on all patients using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy). The CSO topography system analyzes a total of 6144 corneal points of a corneal area within a circular annulus outlined by an inner radius of 0.33 mm and an outer

group 3

PRK

Group Type ACTIVE_COMPARATOR

Laser refractive surgery

Intervention Type PROCEDURE

This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).

All patients will be subjected to routine comprehensive preoperative examinations including manifest uncorrected distant visual acuity (UCDVA), best corrected distant visual acuity (BCDVA), slit-lamp examination, intraocular pressure, and fundus examination.

Corneal topography and corneal aberrometry will be performed on all patients using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy). The CSO topography system analyzes a total of 6144 corneal points of a corneal area within a circular annulus outlined by an inner radius of 0.33 mm and an outer

Interventions

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Laser refractive surgery

This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).

All patients will be subjected to routine comprehensive preoperative examinations including manifest uncorrected distant visual acuity (UCDVA), best corrected distant visual acuity (BCDVA), slit-lamp examination, intraocular pressure, and fundus examination.

Corneal topography and corneal aberrometry will be performed on all patients using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy). The CSO topography system analyzes a total of 6144 corneal points of a corneal area within a circular annulus outlined by an inner radius of 0.33 mm and an outer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Age: 18 - 45 years old.

Refraction:

Low and moderate grades of myopia will be included:

(According to manifest refraction) low (\[0\] - ≤ \[-3\] diopters) Moderate (\[-3\] - ≤ \[-6\] diopters) With cylinder ≤ \[-1.5\] diopters.

Exclusion Criteria

Any ocular surgery or medication, corneal opacities, pregnancy, lactation and keratoconus.
Minimum Eligible Age

18 Weeks

Maximum Eligible Age

45 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdeen Refai

Master degree ophthalmology department faculty of medicine Sohag University

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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ahmed abdeen, Master

Role: CONTACT

+201003700245

Other Identifiers

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Soh-Med-24-12-4MD

Identifier Type: -

Identifier Source: org_study_id

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