CClinicalTrials.gg
Status unknownNCT04109040Updated Nov 30, 2020

Patients' Satisfaction After LASIK

An observational study in Refractive Errors, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-11-30.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

The feeling of sight in human is usually taken as the most significant factor for fathoming and receiving data from environment and, thus, assumes a significant role in regulating most human exercises and practices. Accordingly, any harm to this sense may significantly influence an individual's adjustment with environment.1

Refractive error can be explained as an eye condition in which incoming light rays are not focused on the photoreceptor layer of the fovea, resulting in blurred vision. Of the refractive errors, myopia, hyperopia, and astigmatism are the 3 most common types. In myopia, the incoming light rays are focused in front of the fovea, whereas in hyperopia, they are focused beyond the fovea. Astigmatism is typically explained by irregularities in the cornea (corneal astigmatism) and crystalline lens (lenticular astigmatism), which results in differential focusing of parallel rays through different corneal and lenticular meridians.The refractive surgery has a very important role helping subjects to get rid of contact lenses and spectacules.2-3

Laser-assisted in situ keratomileusis (LASIK) is the most popular refractive surgery performed to correct refractive errors of the eye, including myopia, hyperopia, and astigmatism. LASIK surgery has been reported to yield significantly improved patient reported visual outcomes.1 The result is the patient's independence from glasses and contact lenses. Many studies have reported that LASIK surgery can improve not only visual function,1 but also patients' quality of life (QOL).2,4-10

Patient-reported outcomes also revealed that LASIK can maximize patient satisfaction and quality of life by minimizing the onset of visual and dry eye symptoms.11 Happiness or positive emotions are now regarded as a critical component of health.12 With the introduction of the discipline of positive psychology in the late 1990s, many scientific investigations of happiness have resulted in the development of the proposal that happiness or positive emotions are highly beneficial for physical and mental health.12-19

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Conditions studied

  • Refractive Errors

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03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Deviceslit lamp

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

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What researchers measure

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

    Time frame: LASIK

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 27893063 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04109040
Lead sponsor
Assiut University
Responsible party
Sara Mohamed Sayed Mohamed (post gradute doctor, Assiut University) — Principal investigator
First posted
Sep 30, 2019
Start date
Jan 2021 (estimated)
Primary completion
Jan 2022 (estimated)
Completion
Nov 2022 (estimated)
Last update
Nov 30, 2020

Study contacts

Sara Mohamed, post graduate
Contact
saraotafi@yahoo.com
+201110326501
Khaled Abdelazeem, Associate Professor
Contact
abdelazeem.kh@aun.edu.eg
+201114001717

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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