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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 : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Edward E. Manche, Stanford University

Tracking Information
First Submitted Date September 28, 2015
First Posted Date October 15, 2015
Last Update Posted Date October 20, 2020
Actual Study Start Date July 2015
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 13, 2015)
Self-reported quality of vision and quality of life questionnaire [ Time Frame: Twleve months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 13, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Evaluation of LASIK, SMILE and PRK Surgery in Physicians
Official Title An Evaluation of Quality of Vision and Quality of Life With LASIK, SMILE and PRK Surgery in Physicians
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Physicians with refractive errors
Condition
  • Nearsightedness
  • Farsightedness
  • Astigmatism
Intervention Behavioral: Questionnaire (QoV questionnaire)
Quality of vision and quality of life questionnaire
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 18, 2016)
700
Original Estimated Enrollment
 (submitted: October 13, 2015)
350
Estimated Study Completion Date January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 62 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Linda Schwartz 650 498-7020
Contact: Linda Schwartz
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02576483
Other Study ID Numbers 34287
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Edward E. Manche, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Edward E. Manche, MD Stanford University
PRS Account Stanford University
Verification Date October 2020