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Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

Primary Purpose

Myopia, Astigmatism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topography Guided LASIK Surgery
Small Incision Lenticule Extraction Surgery
Sponsored by
Hoopes Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring refractive surgery, myopia, astigmatism, excimer laser, femtosecond laser, VARIO Topolyzer, Lenticule

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 22-50 at the time of consent Diagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent of refraction of ≥ -2.00 and ≤ -9.00 D Preop Spherical component of ≥ -2.00 and ≤ -8.00 D Refractive Cylinder of ≤ -3.00 D BCVA of 20/20 or better in each eye Subjects must have a stable refraction which is defined as change in spherical equivalent no greater than 0.50 D comparing screening visit manifest refraction to previous refractions over one year period prior to surgery. (spectacle Rx, or contact lens Rx) Subjects who are contact lens wearers must have hard or gas permeable lenses discontinued for at least 4 weeks and soft lenses discontinued for at least 5 days prior to the preoperative screening evaluation. Hard or gas permeable lens wearers must not return to contact lens use before surgery and soft lens wearers must discontinue use at least 5 days before surgery. Acceptable topography and baseline examination results for refractive procedures as determined by Principal Investigator or Co-Investigator Surgical plan includes treatment target for emmetropia in both eyes and no monovision. Subject is capable and willing to use postoperative medications as prescribed. Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits. Subjects are willing and able to return for all postoperative examinations. Exclusion Criteria: Clinically significant dry eye on clinical examination as determined by the investigator Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topography History of corneal dystrophies or guttata History of herpetic keratitis or active disease History of prior refractive surgery History of glaucoma or glaucoma suspect History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease. Females who are pregnant, breast-feeding, or intend to become pregnant any time during the course of the study as determined by verbal inquiry. The Principal Investigator has determined the subject not to be a good candidate for the study

Sites / Locations

  • Hoopes VisionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Topography-Guided LASIK

Small Incision Lenticule Extraction

Arm Description

Subjects receive Topography-Guided LASIK surgery on one eye.

Subjects receive Small Incision Lenticule Extraction surgery on one eye.

Outcomes

Primary Outcome Measures

Uncorrected Visual Acuity
Percentage of eyes with Uncorrected Visual Acuity of 20/20 or better
Corrected Visual Acuity
Percentage of eyes with Corrected Visual Acuity of 20/20 or better

Secondary Outcome Measures

Predictability of Intended Outcome
Percentage of eyes with refractive error within +/- 0.50 D MRSE and +/- 1.00 D MRSE of intended correction

Full Information

First Posted
October 27, 2022
Last Updated
November 7, 2022
Sponsor
Hoopes Vision
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05611294
Brief Title
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
Official Title
A Visual Outcome Comparison of Topography Guided LASIK Versus Small Incision Lenticule Extraction: A Prospective Contralateral Eye Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
August 11, 2024 (Anticipated)
Study Completion Date
August 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoopes Vision
Collaborators
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates differences in postoperative visual outcomes between patients receiving Topography-Guided LASIK in one eye and Small Incision Lenticule Extraction in the other eye.
Detailed Description
This is a prospective, randomized, simultaneous, contralateral eye study including at least 42 patients undergoing refractive correction surgery. Patients will be selected from the Hoopes Vision patient population after a preliminary refractive evaluation has been completed. Patients who express an interest in the study will be consented. After informed consent has been obtained and the patient has completed a screening exam and met all study criteria they will be considered enrolled. Randomization will ensure 50% of Right Eyes will receive Topography-Guided LASIK and 50% of Right Eyes will receive Small Incision Lenticule Extraction. Subjects will be given postoperative care instructions and medications following standard of care practices. Subjects will return for a 1-day, 1-week, 1-month, 3-month, and 12-month visit. Retreatments may only occur after all postoperative study visits have been completed and/or the subject has exited the study. At the preliminary screening visit, 1-month, 3-month, and 12-mont postoperative visits, patients will complete a Patient Participant Questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
Keywords
refractive surgery, myopia, astigmatism, excimer laser, femtosecond laser, VARIO Topolyzer, Lenticule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Contralateral Eye to Eye Comparison
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topography-Guided LASIK
Arm Type
Active Comparator
Arm Description
Subjects receive Topography-Guided LASIK surgery on one eye.
Arm Title
Small Incision Lenticule Extraction
Arm Type
Active Comparator
Arm Description
Subjects receive Small Incision Lenticule Extraction surgery on one eye.
Intervention Type
Device
Intervention Name(s)
Topography Guided LASIK Surgery
Intervention Description
LASIK surgery, using corneal topography data in treatment profile, to correct myopia or myopia with astigmatism refractive error.
Intervention Type
Device
Intervention Name(s)
Small Incision Lenticule Extraction Surgery
Intervention Description
Corneal lenticule formation using a femtosecond laser, with subsequent lenticule extraction, to correct myopia or myopia with astigmatism refractive error.
Primary Outcome Measure Information:
Title
Uncorrected Visual Acuity
Description
Percentage of eyes with Uncorrected Visual Acuity of 20/20 or better
Time Frame
12 months
Title
Corrected Visual Acuity
Description
Percentage of eyes with Corrected Visual Acuity of 20/20 or better
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Predictability of Intended Outcome
Description
Percentage of eyes with refractive error within +/- 0.50 D MRSE and +/- 1.00 D MRSE of intended correction
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 22-50 at the time of consent Diagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent of refraction of ≥ -2.00 and ≤ -9.00 D Preop Spherical component of ≥ -2.00 and ≤ -8.00 D Refractive Cylinder of ≤ -3.00 D BCVA of 20/20 or better in each eye Subjects must have a stable refraction which is defined as change in spherical equivalent no greater than 0.50 D comparing screening visit manifest refraction to previous refractions over one year period prior to surgery. (spectacle Rx, or contact lens Rx) Subjects who are contact lens wearers must have hard or gas permeable lenses discontinued for at least 4 weeks and soft lenses discontinued for at least 5 days prior to the preoperative screening evaluation. Hard or gas permeable lens wearers must not return to contact lens use before surgery and soft lens wearers must discontinue use at least 5 days before surgery. Acceptable topography and baseline examination results for refractive procedures as determined by Principal Investigator or Co-Investigator Surgical plan includes treatment target for emmetropia in both eyes and no monovision. Subject is capable and willing to use postoperative medications as prescribed. Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits. Subjects are willing and able to return for all postoperative examinations. Exclusion Criteria: Clinically significant dry eye on clinical examination as determined by the investigator Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topography History of corneal dystrophies or guttata History of herpetic keratitis or active disease History of prior refractive surgery History of glaucoma or glaucoma suspect History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease. Females who are pregnant, breast-feeding, or intend to become pregnant any time during the course of the study as determined by verbal inquiry. The Principal Investigator has determined the subject not to be a good candidate for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven H Linn, OD
Phone
801-568-0200
Email
slinn@hoopesvision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michele R Avila, OD
Phone
801-568-0200
Email
mavila@hoopesvision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majid Moshirfar, MD
Organizational Affiliation
Hoopes Vision
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoopes Vision
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven H Linn, OD
Phone
801-568-0200
Email
slinn@hoopesvision.com
First Name & Middle Initial & Last Name & Degree
Michele R Avila, OD
Phone
801-568-0200
Email
mavila@hoopesvision.com
First Name & Middle Initial & Last Name & Degree
Majid Moshirfar, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with other researchers outside of those participating in this specific study.

Learn more about this trial

Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

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