An Evaluation of Quality of Vision and Quality of Life With LASIK, SMILE and PRK Surgery in Physicians
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nearsightedness
- Sponsor
- Stanford University
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Self-reported quality of vision and quality of life questionnaire
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The principle investigator is evaluating self-reported quality of vision and quality of life in physicians undergoing LASIK, SMILE and PRK surgery.
Detailed Description
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.
Investigators
Edward E. Manche
Principal Investigator
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Self-reported quality of vision and quality of life questionnaire
Time Frame: Twleve months
Secondary Outcomes
- Changes in CDVA (Corrected distance visual acuity)(Preoperatively, one, three, six and twelve months)
- Predictability (Percentage of eyes within 0.25, +/- 0.50 and +/- 1.00 diopters of the intended correction(Preoperatively, one, three, six and twelve months)
- Self-reported quality of life and quality of vision (QoV questionnaire)(Preoperatively, one, three and six months)
- Changes in low contrast acuity (5% and 25% contrast acuity)(Preoperatively, one, three, six and twelve months)