Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

July 31, 2024 updated by: Hoopes Vision

A Visual Outcome Comparison of Topography Guided LASIK Versus Small Incision Lenticule Extraction: A Prospective Contralateral Eye Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Draper, Utah, United States, 84020
        • Hoopes Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 22-50 at the time of consent
  2. Diagnosis of myopia or myopia with astigmatism with Preop manifest spherical equivalent of refraction of ≥ -2.00 and ≤ -9.00 D
  3. Preop Spherical component of ≥ -2.00 and ≤ -8.00 D
  4. Refractive Cylinder of ≤ -3.00 D
  5. BCVA of 20/20 or better in each eye
  6. 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)
  7. 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.
  8. Acceptable topography and baseline examination results for refractive procedures as determined by Principal Investigator or Co-Investigator
  9. Surgical plan includes treatment target for emmetropia in both eyes and no monovision.
  10. Subject is capable and willing to use postoperative medications as prescribed.
  11. Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.
  12. Subjects are willing and able to return for all postoperative examinations.

Exclusion Criteria:

  1. Clinically significant dry eye on clinical examination as determined by the investigator
  2. Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal topography
  3. History of corneal dystrophies or guttata
  4. History of herpetic keratitis or active disease
  5. History of prior refractive surgery
  6. History of glaucoma or glaucoma suspect
  7. History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.
  8. Females who are pregnant, breast-feeding, or intend to become pregnant any time during the course of the study as determined by verbal inquiry.
  9. The Principal Investigator has determined the subject not to be a good candidate for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topography-Guided LASIK
Subjects receive Topography-Guided LASIK surgery on one eye.
Device: Topography Guided LASIK Surgery
LASIK surgery, using corneal topography data in treatment profile, to correct myopia or myopia with astigmatism refractive error.
Active Comparator: Small Incision Lenticule Extraction
Subjects receive Small Incision Lenticule Extraction surgery on one eye.
Device: Small Incision Lenticule Extraction Surgery
Corneal lenticule formation using a femtosecond laser, with subsequent lenticule extraction, to correct myopia or myopia with astigmatism refractive error.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Visual Acuity
Time Frame: 12 months
Percentage of eyes with Uncorrected Visual Acuity of 20/20 or better
12 months
Corrected Visual Acuity
Time Frame: 12 months
Percentage of eyes with Corrected Visual Acuity of 20/20 or better
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictability of Intended Outcome
Time Frame: 12 months
Percentage of eyes with refractive error within +/- 0.50 D MRSE and +/- 1.00 D MRSE of intended correction
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoopes Vision

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Majid Moshirfar, MD, Hoopes Vision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDRR-CON2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared with other researchers outside of those participating in this specific study.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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