Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles

NCT ID: NCT04452448

Last Updated: 2020-06-30

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2020-06-10

Brief Summary

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This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Detailed Description

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The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser in situ keratomileusis

A prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK)

Group Type EXPERIMENTAL

LASIK

Intervention Type DEVICE

All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.

Interventions

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LASIK

All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Myopia up to -8.0 D and astigmatism up to -2.0D.
2. Cases above 18 years of age with a stable refraction for at least one year.

Exclusion Criteria

1. Keratoconus.
2. Patients with collagen diseases.
3. Previous LASIK or any other refractive surgery.
4. Severe dry eye syndrome.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ehab Mossallam, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria Faculty of Medicine

Locations

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Alexandria Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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030490

Identifier Type: -

Identifier Source: org_study_id