LASIK vs ICL for Near-sightedness (EVOlve Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vance Thompson Vision
No Placebo Group
Trial Summary
What is the purpose of this trial?Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.
How does the EVO-ICL treatment differ from LASIK for near-sightedness?
EVO-ICL involves implanting a special lens inside the eye, which can provide better night vision and more stable vision correction compared to LASIK, which reshapes the cornea with a laser. Unlike LASIK, EVO-ICL does not require removing any corneal tissue and is reversible.
23679Is the EVO-ICL safe for correcting vision problems?
The EVO-ICL has been shown to be safe for correcting vision problems, with studies reporting low rates of complications like cataracts and high patient satisfaction. Safety data from thousands of eyes indicate improved safety compared to earlier models, making it a reliable option for vision correction.
145810What data supports the effectiveness of the treatment EVO-ICL for near-sightedness?
Research shows that the EVO-ICL is effective for correcting a wide range of vision problems, including myopia (nearsightedness), with high levels of clear vision after surgery and stable results over time. Studies involving thousands of eyes have demonstrated its safety and effectiveness, making it a reliable option for improving vision.
25679Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator to get a clear answer based on your specific situation.
Eligibility Criteria
This trial is for individuals with near-sightedness, possibly also having astigmatism, who are seeking vision correction. Specific eligibility criteria details were not provided.Inclusion Criteria
I am between 21 and 45 years old.
Participant Groups
The study compares two types of vision correction procedures: LASIK, a laser surgery reshaping the cornea; and EVO-ICL placement, where a lens is implanted inside the eye.
2Treatment groups
Active Control
Group I: Implantable Collamer Lens placementActive Control1 Intervention
EVO ICL
Group II: Laser-assisted in Situ KeratomileusisActive Control1 Intervention
LASIK-Wavefront Optimized
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Slade & Baker VisionHouston, TX
Carolina Eyecare PhysiciansMount Pleasant, SC
Vance Thompson Vision ClinicSioux Falls, SD
Kugler VisionOmaha, NE
More Trial Locations
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Who is running the clinical trial?
Vance Thompson VisionLead Sponsor
References
Traumatic cataract and other adverse events with the implantable contact lens. [2022]To evaluate the surgical outcome and adverse events associated with implantation of the implantable contact lens (ICL) for the correction of high myopia or high hyperopia.
Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. [2022]To compare matched populations of LASIK and Visian Implantable Collamer Lens (ICL) cases in the correction of myopia between -3.00 and -7.88 diopters (D).
[Comparison of the two methods, LASIK and ICL in mild and high hyperopia correction--part one]. [2007]The problems of hyperopia surgical correction are complicated. The most used methods are corneal laser treatments (PRK and LASIK), phakic intraocular lenses or clear lens extraction (CLE). The aim of the study was to evaluate and to compare long-term postoperative results of two types of refractive procedures in mild and high hyperopia correction: LASIK and ICL (phakic intraocular posterior chamber contact lens) implantation. The authors evaluated a group of 37 eyes of 20 patients; the average age was 36.3 years +/- 11.8 (SD) and the follow-up period 28.1 months +/- 10.2 (SD) after LASIK procedure, and group of 21 eyes of 13 patients; the average age was 28.6 years +/- 6.1 (SD) and the follow-up period 30.4 months +/- 20.9 (SD) after the ICL implantation. The final uncorrected (UCVA) and best-corrected visual acuity (BCVA) and postoperative refractive error (for far and near) and their development in time were compared. They found statistically significant improvement of the UCVA postoperatively comparing to the preoperative values in both methods (LASIK and ICL) (p 0.05). In hyperopic LASIK, the final BCVA worsened comparing to this before treatment (p > 0.05). The BCVA changes were not statistically significant. The authors also proved better final spherical refraction for far (p 0.05). The stableness of the postoperative cylindrical refraction was also higher in the ICL method during the whole follow up period. Comparing the intraocular procedure (ICL) to the laser method (LASIK), the ICL implantation demonstrates better final BCVA and UCVA and the postoperative refraction is more stable.
Phakic intraocular lenses outcomes and complications: Artisan vs Visian ICL. [2021]To evaluate the safety and visual outcomes of two phakic intraocular lenses (IOLs) for correction of high myopia: Artisan and Visian ICL (ICL).
The Implantable Collamer Lens with a central port: review of the literature. [2020]The purpose of this review is to summarize preclinical and clinical data from publications appearing in the peer-reviewed scientific literature relevant to the safety and effectiveness of the EVO Implantable Collamer Lens (ICL) posterior chamber phakic refractive lens with a central port (V4c Visian ICL with KS Aquaport, STAAR Surgical, Inc.). A literature search was conducted using PubMed.gov to identify all articles relating to the EVO ICL. Articles were examined for their relevance, and the references cited in each article were also searched for additional relevant publications. On the basis of a total of 67 preclinical studies and clinical reports, including effectiveness data on 1,905 eyes with average weighted follow-up of 12.5 months and safety data on 4,196 eyes with weighted average follow up of 14.0 months, the EVO ICL is safe and effective for the correction of a broad range of refractive errors. High levels of postoperative uncorrected visual acuity, refractive predictability, and stability demonstrate the effectiveness of the EVO ICL. Safety data suggest reduced rates of anterior subcapsular cataract and pupillary block compared with earlier models. Improved safety and proven effectiveness make EVO an attractive option for surgeons and patients.
Comparison of visual quality after EVO-ICL implantation and SMILE to select the appropriate surgical method for high myopia. [2020]This study sought to compare the visual quality between intraocular collamer lens (EVO-ICL) implantation and small-incision lenticule extraction (SMILE) and determine the appropriate surgical method to treat patients with high myopia (- 6.25 to - 10 D).
Visual outcomes after small incision lenticule extraction and implantable collamer lens V4c for moderate myopia: 1-year results. [2021]To compare 1-year visual outcomes after implantable collamer lens V4c (EVO-ICL) implantation and small incision lenticule extraction (SMILE) for moderate myopia.
Safety of phakic intraocular collamer lens implantation in 95 highly myopic special-needs children. [2023]To assess the safety of intraocular collamer lens (ICL) implantation in children with high ametropia by reporting rates and case specifics of perioperative and longer-term adverse events (AEs). .
EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism. [2023]Intraocular lens implantation in phakic eyes for the correction of refractive error is currently a widespread procedure. The EVO and EVO+ Visian Implantable Collamer Lenses (ICL) are two of the most prevalent lenses implanted. They incorporate a central orifice to avoid the need for iridotomy. The main difference between both ICL is the higher optical diameter zone provided by the EVO+, allowing a better quality of vision at night. This review aims to provide an overview of the current ICL models available for correcting myopia and myopic astigmatism.
Intraocular Implantable Collamer Lens with a Central Hole Implantation: Safety, Efficacy, and Patient Outcomes. [2023]This review summarizes the available literature and provides updates on the efficacy, safety, and patient outcomes of phakic intraocular lens implantation using implantable collamer lens (ICL), with a focus on newer models with a central port (EVO/EVO+ Visian Implantable Collamer Lens, STAAR Surgical Inc.). All studies included in this review were identified from the PubMed database and were reviewed for relevancy of their topic. Data on hole-ICL implantation performed between October 2018 and October 2022 in 3399 eyes showed a weighted average efficacy index of 1.03 and a weighted average safety index of 1.19 within an average follow-up of 24.7 months. The incidence of complications such as elevated intraocular pressure, cataract, and corneal endothelial cell loss was low. Moreover, both quality of vision and quality of life improved after ICL implantation, confirming the benefits of this procedure. In conclusion, ICL implantation is a promising refractive surgery alternative to laser vision correction with excellent efficacy, safety, and patient outcomes.