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

NCT06860061 | Not Yet Recruiting

• 1 other identifier: Soh-Med-24-12-4MD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Changes of corneal higher-order aberrations

  Corneal aberrometry will be performed using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy).

  1 year

• Changes of total ocular higher-order aberrations

  Wavefront refraction will be acquired by the iDesign aberrometer (Hartmann-Shack Aberrometer)

  1 year

Study Arms (3)

group 1

ACTIVE COMPARATOR

Conventional Lasik

Procedure: Laser refractive surgery

group 2

ACTIVE COMPARATOR

Femto LASIK

Procedure: Laser refractive surgery

group 3

ACTIVE COMPARATOR

PRK

Procedure: Laser refractive surgery

Interventions

Laser refractive surgery 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 1; group 2; group 3

Eligibility Criteria

• Age: 18 Weeks - 45 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Any ocular surgery or medication, corneal opacities, pregnancy, lactation and keratoconus.

Sponsors & Collaborators

• Sohag University: lead

Central Study Contacts

ahmed abdeen, Master

CONTACT

+201003700245; ophthabdeen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree ophthalmology department faculty of medicine Sohag University

Model Details: 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).

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-02