An Evaluation of LASIK, SMILE and PRK Surgery in Physicians
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02576483|
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : August 27, 2019
|Condition or disease||Intervention/treatment|
|Nearsightedness Farsightedness Astigmatism||Behavioral: Questionnaire (QoV questionnaire)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||An Evaluation of Quality of Vision and Quality of Life With LASIK, SMILE and PRK Surgery in Physicians|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2025|
- Behavioral: Questionnaire (QoV questionnaire)
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576483
|Contact: Linda Schwartz||650 498-7020|
|Contact: Linda Schwartz|
|United States, California|
|Byers Eye Institute at Stanford||Recruiting|
|Palo Alto, California, United States, 94303|
|Contact: Linda Schwartz, HS 650-498-7020 firstname.lastname@example.org|
|Principal Investigator: Edward E Manche, MD|
|Principal Investigator:||Edward E. Manche, MD||Stanford University|