Measuring Outcomes of LASIK and EVO-ICL in Matched Populations

NCT06700460 | Recruiting FDA Device

• 1 other identifier: KJF-726
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 5

Brief Summary

Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.

Conditions

Myopia

Keywords

LASIK; EVO ICL; Myopia; Clinical Outcomes

Outcome Measures

Primary Outcomes (8)

• Visual Acuity

  Uncorrected distance visual acuity and Corrected distance visual acuity

  1 month

• Manifest refractive spherical equivalent

  Manifest refraction spherical equivalent (MRSE) is a measurement used in eye care to determine the overall refractive error of the eye, taking into account both nearsightedness or farsightedness (spherical component) and astigmatism (cylindrical component). It's calculated by adding the sphere power and half of the cylinder power

  1 month

• Abberometry (Higher Order Abberations and Corneal Performance Index)

  Aberrometry is a technique used to measure the optical aberrations of the eye, including both lower-order aberrations (LOAs) and higher-order aberrations (HOAs). LOAs are the standard refractive errors, such as nearsightedness, farsightedness, and astigmatism, which can be corrected with glasses or contact lenses. HOAs, on the other hand, are more complex aberrations that affect the quality of vision, even if the LOAs are corrected. HOAs are caused by irregularities in the shape of the cornea or lens. They can cause a variety of visual symptoms, including blurry vision, glare, halos, and difficulty seeing at night

  1 month

• Objective Scatter Index

  The Objective Scatter Index (OSI) is a measurement used in ophthalmology to assess the quality of the eye's optical media, particularly the cornea and lens. It quantifies the amount of light scatter within the eye, which can affect visual clarity and contrast sensitivity.

  1 month

• Contrast Sensitivity

  Contrast sensitivity is the ability to distinguish between objects with varying degrees of contrast, especially in situations of low light or when objects have subtle differences in shading.

  1 month

• Tear Film Stability

  Tear film stability refers to the ability of the tear film, a thin layer of fluid that covers the surface of the eye, to remain intact and maintain a smooth, even surface. This is essential for clear vision and healthy ocular surface.

  1 month

• Ocular Adverse Events in treated eyes/safety

  Ocular adverse events (OAEs) are side effects that can occur in the eye after receiving a treatment, such as medication, surgery, or radiation therapy. These events can range from mild and temporary to severe and permanent.

  1 month

• Subjective Questionnaires and Open-Ended Questions

  Subjective questionnaires and open-ended questions are two common methods used in research to gather qualitative data. They allow researchers to delve deeper into participants' thoughts, feelings, and experiences, providing rich insights that quantitative methods may not capture.

  1 month

Study Arms (2)

Laser-assisted in Situ Keratomileusis

ACTIVE COMPARATOR

LASIK-Wavefront Optimized

Device: Implantable Collamer Lens placement

Implantable Collamer Lens placement

ACTIVE COMPARATOR

EVO ICL

Device: Laser-assisted in Situ Keratomileusis

Interventions

Laser-assisted in Situ Keratomileusis DEVICE

LASIK

Implantable Collamer Lens placement

Implantable Collamer Lens placement DEVICE

EVO ICL

Laser-assisted in Situ Keratomileusis

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Preoperatively the Investigator will evaluate each study subject and refer to the directions for use for EVO+ ICL and Wavefront-Optimized LASIK to confirm the subject's suitability to proceed with bilateral EVO+ ICL Implantation or bilateral Wavefront-optimized LASIK in accordance with the Investigator's standard of care for each procedure. To ensure similar characteristics across study subjects, the Investigator will also adhere to the following criteria for each group:
• Subjects ages 21 to 45 years old.
• Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator.
• Myopia or myopia with astigmatism with spherical equivalent ranging from -3.00 D to ≤ -8.00 D (in the spectacle plane) and cylinder in the range of 0.00 D to 4.00 D (in the spectacle plane).
• Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.
• Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest refraction spherical equivalent (MRSE) of ≤0.75 D.
• Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
• Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.

You may not qualify if:

• \. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
• \. Dry eye syndrome that is unable to be controlled with ocular lubricant(s) or medication(s) and which may confound study outcomes in the opinion of the Investigator.
• \. Serious acute, chronic, or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, uncontrolled diabetes, etc.), in the opinion of the Investigator.
• \. Ocular condition (other than high myopia) that may predispose the subject to future complications, in the opinion of the Investigator. For example:
• Pigment dispersion,
• History or clinical signs of iritis/uveitis,
• History of previous ocular surgery,
• Monocular subjects,
• History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.),
• Evidence of retinal vascular disease,
• Keratoconus or keratoconus suspect,
• Glaucoma or glaucoma suspect by exam findings,
• Ocular surface disease other than controlled dry eye syndrome. 5. Subjects who do not qualify for both study arms:
• Bilateral Wavefront Optimized LASIK
• Bilateral EVO+ ICL implantation

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (5)

Kugler Vision

Omaha, Nebraska, 68118, United States

NOT YET RECRUITING

Cleveland Eye Clinic

Cleveland, Ohio, 44035, United States

NOT YET RECRUITING

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Slade & Baker Vision

Houston, Texas, 77027, United States

RECRUITING

Related Publications (8)

• Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T. Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire. Cornea. 2013 Sep;32(9):1204-10. doi: 10.1097/ICO.0b013e318294b0c0.

  PMID: 23846405 BACKGROUND

• Hays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology. 2003 Dec;110(12):2292-301. doi: 10.1016/j.ophtha.2002.07.001.

  PMID: 14644710 BACKGROUND

• Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 Sep;111(9):1683-92. doi: 10.1016/j.ophtha.2004.03.026.

  PMID: 15350323 BACKGROUND

• Directions for Use, EVO Visian® ICL (Implantable Collamer® Lens)." Accessed April 1, 2024. https://edfu.staar.com/edfu/.

  BACKGROUND

• Moshirfar M, Durnford K, Megerdichian A, Thomson A, Martheswaran T, West W Jr, McCabe S, Ronquillo Y, Hoopes P. Refractive Outcomes After LASIK for the Treatment of Mixed Astigmatism with the Allegretto WaveLight EX500. Ophthalmol Ther. 2022 Apr;11(2):785-795. doi: 10.1007/s40123-022-00472-4. Epub 2022 Feb 15.

  PMID: 35167040 BACKGROUND

• U.S. Food and Drug Administration. "PMA-P030008: WAVELIGHT EXCIMER LASER SYSTEM. "Accessed.fda.gov, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030008S006. Accessed 01Apr2024.

  BACKGROUND

• Meidani A, Tzavara C. Comparison of efficacy, safety, and predictability of laser in situ keratomileusis using two laser suites. Clin Ophthalmol. 2016 Aug 24;10:1639-46. doi: 10.2147/OPTH.S110626. eCollection 2016.

  PMID: 27601880 BACKGROUND

• Du H, Zhang B, Wang Z, Xiong L. Quality of vision after myopic refractive surgeries: SMILE, FS-LASIK, and ICL. BMC Ophthalmol. 2023 Jun 26;23(1):291. doi: 10.1186/s12886-023-03045-6.

  PMID: 37365492 BACKGROUND

MeSH Terms

Conditions

Myopia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Central Study Contacts

Kristin L Dunne

CONTACT

1-877-522-3937; kristin.dunne@vancethompsonvision.com

Study Design

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

Model Details: All LASIK procedures in this study are to be Wavefront Optimized treatments. To ensure standardization of treatments within the LASIK cohort, Wavefront-Guided and Topography-Guided treatments are prohibited. The EX500 laser, an excimer laser, employes a 1050 Hz multidimensional active tracker, online optical pachymetry, an onboard nitrogen generator and a 500 Hz laser pulse frequency that enables the treatment of each D of myopia in 1.4 seconds. The EX500 laser will perform the wavefront refraction according to the user manual and MOP instructions. Refer to current approved EVO+ ICL Directions for Use (DFU) for surgical instructions.6 Study surgeons will use 2% HPMC OVD for EVO+ ICL surgery as recommended in the DFU.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 22, 2024
• Study Start: November 27, 2024
• Primary Completion: February 28, 2025
• Study Completion: April 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)