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An Evaluation of LASIK, SMILE and PRK Surgery in Physicians

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ClinicalTrials.gov Identifier: NCT02576483
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, 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.

Condition or disease Intervention/treatment
Nearsightedness Farsightedness Astigmatism Behavioral: Questionnaire (QoV questionnaire)

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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Questionnaire (QoV questionnaire)
    Quality of vision and quality of life questionnaire


Primary Outcome Measures :
  1. Self-reported quality of vision and quality of life questionnaire [ Time Frame: Twleve months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Changes in CDVA (Corrected distance visual acuity) [ Time Frame: Preoperatively, one, three, six and twelve months ]
  3. Changes in low contrast acuity (5% and 25% contrast acuity) [ Time Frame: Preoperatively, one, three, six and twelve months ]
  4. Self-reported quality of life and quality of vision (QoV questionnaire) [ Time Frame: Preoperatively, one, three and six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Physicians with refractive errors
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Linda Schwartz 650 498-7020
Contact: Linda Schwartz

Locations
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United States, California
Byers Eye Institute at Stanford Recruiting
Palo Alto, California, United States, 94303
Contact: Linda Schwartz, HS    650-498-7020    lschwartz@stanfordmed.org   
Principal Investigator: Edward E Manche, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Edward E. Manche, MD Stanford University

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Responsible Party: Edward E. Manche, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02576483     History of Changes
Other Study ID Numbers: 34287
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Astigmatism
Myopia
Hyperopia
Refractive Errors
Eye Diseases