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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04109040
Other study ID # LASIK
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2021
Est. completion date November 2022

Study information

Verified date November 2020
Source Assiut University
Contact Sara Mohamed, post graduate
Phone +201110326501
Email saraotafi@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date November 2022
Est. primary completion date January 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: Patients with myopia less than -10 Diopters Patients with hyperopia less than + 6 Diopters 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
slit lamp
diagnostice device to examine anterior segment of the eye and for fundus examination

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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