NCT04109040

Brief Summary

The aim of this study is to evaluate the level of satisfaction, functional vision and quality of life outcome of patients after LASIK surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Status
unknown

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

First Submitted

Initial submission to the registry

September 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

September 27, 2019

Last Update Submit

November 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • patients' satisfaction after LASIK

    to evaluate the level of satisfaction and quality of life outcome of patients after LASIK surgery and funtional vision to improve quality of life and help patients to get rid of glasses

    LASIK

Interventions

slit lampDEVICE

diagnostice device to examine anterior segment of the eye and for fundus examination

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population included were both males and females in private LASIK center . The inclusion criteria are patients who have suffered from refractive errors aged from 18 - 55years old and patients who have done LASIK within one year for at least 3 monthes will be included in the study.

You may qualify if:

  • Patients with myopia less than -10 Diopters Patients with hyperopia less than + 6 Diopters

You may not qualify if:

  • Patients of eye disease that may interfere with the results of the study. Previous ocular surgery. Patients using psychiatric medication will not be included in the study. Unwillingness to participate in the study. Subjects who did not respond to all questions were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hays RD, Tarver ME, Spritzer KL, Reise S, Hilmantel G, Hofmeister EM, Hammel K, May J, Ferris F 3rd, Eydelman M. Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL). JAMA Ophthalmol. 2017 Jan 1;135(1):3-12. doi: 10.1001/jamaophthalmol.2016.4597.

    PMID: 27893063BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Interventions

Slit Lamp

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

OphthalmoscopesDiagnostic EquipmentEquipment and Supplies

Central Study Contacts

Sara Mohamed, post graduate

CONTACT

Khaled Abdelazeem, Associate Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post gradute doctor

Study Record Dates

First Submitted

September 27, 2019

First Posted

September 30, 2019

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

November 1, 2022

Last Updated

November 30, 2020

Record last verified: 2020-11