NCT04452448

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 10, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

2.4 years

First QC Date

June 26, 2020

Last Update Submit

June 26, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

  • Evaluation of ocular aberrations

    3\. Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery

    3 months

  • Visual acuity

    Unaided as well as best corrected visual acuity

    3 months

  • Manifest refraction

    Manifest refraction

    3 months

Study Arms (1)

Laser in situ keratomileusis

EXPERIMENTAL

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

Device: LASIK

Interventions

LASIKDEVICE

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.

Laser in situ keratomileusis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Keratoconus.
  • Patients with collagen diseases.
  • Previous LASIK or any other refractive surgery.
  • Severe dry eye syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Myopia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ehab Mossallam, PhD

    Alexandria Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

June 30, 2020

Study Start

January 10, 2018

Primary Completion

May 30, 2020

Study Completion

June 10, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)