Refractive ErrorsNCT04109040
Patients' Satisfaction After LASIK
An observational study of Refractive Errors, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- slit lamp
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
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.
Who may be able to join
- Patients with myopia less than -10 Diopters Patients with hyperopia less than + 6 Diopters
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Refractive Errors
- Being tested
- slit lamp
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slit lampDevice
diagnostice device to examine anterior segment of the eye and for fundus examination
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: LASIK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Sayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109040
- Sponsor's protocol ID
- LASIK
- Status last verified
- Nov 2020
- First submitted
- 27 Sep 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Satisfaction After LASIK
- ClinicalTrials.gov ID
- NCT04109040
- Acronym / sponsor ID
- LASIK
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the level of satisfaction, functional vision and quality of life outcome of patients after LASIK surgery.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Patients with myopia less than -10 Diopters Patients with hyperopia less than + 6 Diopters
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| slit lampdiagnostice device to examine anterior segment of the eye and for fundus examination | Device | – |
Primary outcome
patients' satisfaction after LASIK
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background: PubMed 27893063Hays 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Mohamed, post graduate (+201110326501, saraotafi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients' satisfaction after LASIK (time frame: LASIK). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04109040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.