Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction

NCT05611294 | Active Not Recruiting FDA Device

• 1 other identifier: HDRR-CON2022
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Astigmatism

Keywords

refractive surgery; myopia; astigmatism; excimer laser; femtosecond laser; VARIO Topolyzer; Lenticule

Outcome Measures

Primary Outcomes (2)

• Uncorrected Visual Acuity

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

  12 months

• Corrected Visual Acuity

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

  12 months

Secondary Outcomes (1)

• Predictability of Intended Outcome

  12 months

Study Arms (2)

Topography-Guided LASIK

ACTIVE COMPARATOR

Subjects receive Topography-Guided LASIK surgery on one eye.

Device: Topography Guided LASIK Surgery

Small Incision Lenticule Extraction

ACTIVE COMPARATOR

Subjects receive Small Incision Lenticule Extraction surgery on one eye.

Device: Small Incision Lenticule Extraction Surgery

Interventions

Topography Guided LASIK Surgery DEVICE

LASIK surgery, using corneal topography data in treatment profile, to correct myopia or myopia with astigmatism refractive error.

Topography-Guided LASIK

Small Incision Lenticule Extraction Surgery DEVICE

Corneal lenticule formation using a femtosecond laser, with subsequent lenticule extraction, to correct myopia or myopia with astigmatism refractive error.

Small Incision Lenticule Extraction

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoopes Vision: lead
• Alcon Research: collaborator

Study Sites (1)

Hoopes Vision

Draper, Utah, 84020, United States

Location

Related Publications (1)

• Moin KA, Manion GN, Pandiri S, Hoopes PC, Moshirfar M. Three-Month Comprehensive Outcomes of Topography-Guided LASIK Versus Keratorefractive Lenticule Extraction (KLEx): A Prospective Contralateral Study. Ophthalmol Ther. 2024 Aug;13(8):2265-2284. doi: 10.1007/s40123-024-00987-y. Epub 2024 Jul 1.

  PMID: 38951314 DERIVED

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Majid Moshirfar, MD

  Hoopes Vision

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Contralateral Eye to Eye Comparison

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 10, 2022
• Study Start: September 27, 2022
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)