An Evaluation of LASIK, SMILE and PRK Surgery in Physicians



Status:Recruiting
Conditions:Ocular, Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:21 - 62
Updated:4/26/2018
Start Date:July 2015
End Date:January 2025
Contact:Linda Schwartz
Phone:650 498-7020

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An Evaluation of Quality of Vision and Quality of Life With LASIK, SMILE and PRK Surgery in Physicians

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.

Inclusion criteria.

- 21 years or older.

- A physician or medical student.

- 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, SMILE or PRK procedure
based on the investigator's assessment of medical and ophthalmic health, general
cognitive function, and physical and social limitations.

- 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.

Exclusion criteria.

- Subjects under the age of 21.

- Patients with excessively thin corneas.

- Patients with topographic evidence of keratoconus.

- Patients with ectatic eye disorders.

- Patients with autoimmune diseases.

- Patients who are pregnant or nursing.
We found this trial at
1
site
Palo Alto, California 94303
Principal Investigator: Edward E Manche, MD
Phone: 650-498-7020
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from
Palo Alto, CA
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