An observational study in Nearsightedness, Farsightedness and Astigmatism, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 62 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Stanford University · Observational
The principle investigator is evaluating self-reported quality of vision and quality of life in physicians undergoing LASIK, SMILE and PRK surgery.
The participants will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the participant from the study, then the investigator will inform the participant and make an appropriate referral. This is standard practice for laser in situ keratomileusis (LASIK) surgery, small incision lenticule extraction (SMILE) and photorefractive keratectomy (PRK) surgery.
If the participant is deemed appropriate for the study after a comprehensive examination including computerized videokeratography, then the participant can be enrolled. These exams are also standard practice for LASIK, SMILE and PRK surgery.
The Quality of Vision (QoV) Questionnaire will be administered following the pre-operative visit during which participants are enrolled and then at the three-month and twelve-month post- op visits before the participants are seen by the principle investigator. The questionnaire is the study intervention.
The participant will undergo bilateral simultaneous LASIK eye surgery, SMILE or PRK surgery. The participants will be seen pre-operatively, on the day of surgery, post op day one, one month, three months, and twelve-months as part of the study. Participants may also be seen more frequently if required from a medical standpoint. The participant will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week to four weeks after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK, SMILE and PRK surgery.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 700 is above the median of 150 across 204 observational studies indexed under Myopia.
Browse Myopia studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Physicians with refractive errors
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Quality of vision and quality of life questionnaire
Self-reported quality of vision and quality of life questionnaire
Time frame: Twleve months
Predictability (Percentage of eyes within 0.25, +/- 0.50 and +/- 1.00 diopters of the intended correction
Time frame: Preoperatively, one, three, six and twelve months
Changes in CDVA (Corrected distance visual acuity)
Time frame: Preoperatively, one, three, six and twelve months
Changes in low contrast acuity (5% and 25% contrast acuity)
Time frame: Preoperatively, one, three, six and twelve months
Self-reported quality of life and quality of vision (QoV questionnaire)
Time frame: Preoperatively, one, three and six months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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