MyopiaNCT02161263
Quality of Vision and Quality of Life With LASIK
An observational study of Myopia and Astigmatism, run by Edward E. Manche at 1 site in United States.
Trial summary
The investigators are administering a validated questionnaire looking at patient reported quality of life and quality of vision after LASIK surgery Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism, Quality of Lifte
- What is being tested?
- Patient Quality of Life andVision after LASIK Surgery
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 1 Feb 2023
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults over the age of 21 with healthy eyes and nearsightedness, farsightedness and/or astigmatism
Who may be able to join
- Are aged 21 years or older.
- Have the ability to give informed consent.
- Speak and read English fluently.
- Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
- May benefit from increased spectacle independence.
- Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations.
Show all 9Show fewer
- Have a treatment target of bilateral emmetropia.
- Express willingness and potential ability to return for all follow-up examinations through the 12-month follow-up exam under the care of the treating investigator.
- Are not enrolled in any other research study.
Who cannot join
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectactic eye disorders.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Eye Laser Center
Palo Alto, California, 94303
About this study
Official title: Patient Quality of Vision and Quality of Life With LASIK Surgery
The investigators are administering a validated questionnaire looking at patient reported quality of life and quality of vision after LASIK surgery
Read the detailed description
The purpose of the study is to evaluate the prevalence of any functional limitations and their associated factors at one, three, six, and twelve months after LASIK surgery and finally the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, six and twelve months following LASIK surgery using two questionnaires.
- Conditions
- Myopia, Astigmatism, Quality of Lifte
- Being tested
- Patient Quality of Life andVision after LASIK Surgery
- Keywords
- LASIK, Satisfaction
- Medical subject headings
- Myopia, Astigmatism, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Quality of Life andVision after LASIK SurgeryOther
Patient questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Quality of Vision after LASIK surgery | Questionnaire Receives: Other: Patient Quality of Life andVision after LASIK Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Vision and Quality of Life Questionnaires after LASIK Surgery
Patients will complete questionnaires preoperatively and postoperatively at month twelve.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start1 Mar 2014
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward E. Manche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward E. Manche, Stanford University
- Investigators
- Edward E Manche, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161263
- Sponsor's protocol ID
- 30301
- Status last verified
- Mar 2024
- First submitted
- 6 Jun 2014
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Quality of Vision and Quality of Life With LASIK Surgery
- ClinicalTrials.gov ID
- NCT02161263
- Acronym / sponsor ID
- 30301
- Conditions
- Myopia, Astigmatism, Quality of Lifte
- Keywords
- LASIK, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Edward E. MancheUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 11 Jun 2014 (estimated)
- 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 investigators are administering a validated questionnaire looking at patient reported quality of life and quality of vision after LASIK surgery
Detailed description
The purpose of the study is to evaluate the prevalence of any functional limitations and their associated factors at one, three, six, and twelve months after LASIK surgery and finally the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, six and twelve months following LASIK surgery using two questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of Vision after LASIK surgery | – | Other: Patient Quality of Life andVision after LASIK SurgeryQuestionnaire |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over the age of 21 with healthy eyes and nearsightedness, farsightedness and/or astigmatism
Key inclusion criteria (9 listed)
- Are aged 21 years or older.
- Have the ability to give informed consent.
- Speak and read English fluently.
- Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
- May benefit from increased spectacle independence.
Key exclusion criteria (6 listed)
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectactic eye disorders.
- Patients with autoimmune diseases.
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 |
|---|---|---|
| Patient Quality of Life andVision after LASIK SurgeryPatient questionnaire | Other | Quality of Vision after LASIK surgery |
Primary outcome
Quality of Vision and Quality of Life Questionnaires after LASIK Surgery
Time frame: 12 months
Patients will complete questionnaires preoperatively and postoperatively at month twelve.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
Edward E Manche, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Astigmatism, run by Edward E. Manche at 1 site in United States.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Vision and Quality of Life Questionnaires after LASIK Surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2024.