Clinical trial NCT06700460: Measuring Outcomes of LASIK and EVO-ICL in Matched Populations
Official title: A Randomized Evaluation of Clinical Outcomes Following Bilateral Implantation of EVO+ ICL Lenses or Bilateral Wavefront-Optimized LASIK (EVOlve)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: LASIK
EVO ICL
Myopia
Clinical Outcomes
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: A randomized evaluation of clinical outcomes following bilateral implantation of EVO+ Visian™ Implantable Collamer™ Lenses or bilateral Wavefront-optimized LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Subjects ages 21 to 45 years old.
  2. Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator.
  3. 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).
  4. Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.
  5. Difference between cycloplegic refraction spherical equivalent (CRSE) and manifest refraction spherical equivalent (MRSE) of ≤0.75 D.
  6. Subjects must be able and willing to return for scheduled follow-up examinations after surgery.
  7. 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.

Exclusion Criteria:

* 1. 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.

  2. 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.

  3. 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.

  4. 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

    6. Subjects who, in the judgment of the Investigator, present any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.

    7. Participation in another clinical trial involving ocular procedures within the last 6-months.

    8. Other conditions or assessment that causes the subject to not be an acceptable candidate for treatment or study participation as clinically assessed and documented by the Investigator.

Primary outcomes:
measure: Visual Acuity
timeFrame: 1 month
measure: Manifest refractive spherical equivalent
timeFrame: 1 month
measure: Abberometry (Higher Order Abberations and Corneal Performance Index)
timeFrame: 1 month
measure: Objective Scatter Index
timeFrame: 1 month
measure: Contrast Sensitivity
timeFrame: 1 month
measure: Tear Film Stability
timeFrame: 1 month
measure: Ocular Adverse Events in treated eyes/safety
timeFrame: 1 month
measure: Subjective Questionnaires and Open-Ended Questions
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Kugler Vision
state: Nebraska
city: Cleveland
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Mt. Pleasant
country: United States
facility: Carolina Eyecare Physicians
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision Clinic
state: South Dakota
city: Houston
country: United States
facility: Slade & Baker Vision
state: Texas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Directions for Use, EVO Visian® ICL (Implantable Collamer® Lens)." Accessed April 1, 2024. https://edfu.staar.com/edfu/.
citation: 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.
citation: 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.
citation: 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.
citation: 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.