Measuring Outcomes of LASIK and EVO-ICL in Matched Populations

NCT ID: NCT06700460

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-27
• Study Completion Date: 2025-04-01

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser-assisted in Situ Keratomileusis

LASIK-Wavefront Optimized

Group Type: ACTIVE_COMPARATOR

Implantable Collamer Lens placement

Intervention Type: DEVICE

EVO ICL

Implantable Collamer Lens placement

EVO ICL

Group Type: ACTIVE_COMPARATOR

Laser-assisted in Situ Keratomileusis

Intervention Type: DEVICE

LASIK

Interventions

Laser-assisted in Situ Keratomileusis

LASIK

Intervention Type: DEVICE

Implantable Collamer Lens placement

EVO ICL

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vance Thompson Vision

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kugler Vision

Omaha, Nebraska, United States

Site Status: NOT_YET_RECRUITING

Cleveland Eye Clinic

Cleveland, Ohio, United States

Site Status: NOT_YET_RECRUITING

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, United States

Site Status: RECRUITING

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, United States

Site Status: RECRUITING

Slade & Baker Vision

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristin L Dunne

Role: CONTACT

kristin.dunne@vancethompsonvision.com

1-877-522-3937

References

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Reference Type: BACKGROUND

PMID: 23846405 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14644710 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15350323 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 35167040 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 27601880 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37365492 (View on PubMed)

Other Identifiers

KJF-726

Identifier Type: -

Identifier Source: org_study_id