An Evaluation of LASIK, SMILE and PRK Surgery in Physicians

Recruiting

• Conditions: Farsightedness; Nearsightedness; Astigmatism

• Registration Number: NCT02576483
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported quality of vision and quality of life questionnaire	Twleve months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States