Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire.
William Ngo, Ping Situ, Nancy Keir...
https://pubmed.ncbi.nlm.nih.gov/23846405Actively Recruiting
Phase Not Applicable
Age: 21Years - 45Years
All Genders
ID06700460
Randomized Study Comparing Vision Outcomes of EVO+ Implantable Collamer Lenses and Wavefront-Optimized LASIK for Myopia Correction
Led by Vance Thompson Vision · Updated on 2025-01-09
56
Participants Needed
5
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of two eye treatments—bilateral implantation of EVO+ Visian Implantable Collamer Lenses (ICLs) and bilateral Wavefront-optimized LASIK—for correcting or reducing myopia with or without astigmatism. This randomized study compares these two procedures to better understand their effects on vision and eye health in adults aged 21 to 45 years. Participants will receive either EVO+ ICL lenses implanted in both eyes or Wavefront-optimized LASIK surgery on both eyes. The study follows standard care practices to ensure subjects are suitable for either treatment and have similar eye characteristics. Both treatments aim to improve vision by correcting refractive errors associated with myopia and astigmatism. During the study, participants will be monitored with various eye tests one month after treatment, including visual acuity, refractive measurements, higher order aberrations, corneal performance, contrast sensitivity, tear film stability, and safety assessments for any eye-related adverse events. Subjective questionnaires and open-ended questions will also gather personal experiences. Participants must be able to attend scheduled follow-up visits and provide informed consent, with the total participation duration involving preoperative evaluation and post-treatment monitoring.
CONDITIONS
Official Title
Measuring Outcomes of LASIK and EVO-ICL in Matched Populations
Who Can Participate
Age: 21Years - 45Years
All Genders
Eligibility Criteria
You may qualify if you...
- Ages 21 to 45 years old
- Stable refractive error for at least one year (change ≤ 0.50 D) or as determined stable by Investigator
- Myopia or myopia with astigmatism with spherical equivalent from -3.00 D to ≤ -8.00 D and cylinder from 0.00 D to 4.00 D
- Corrected distance visual acuity of 20/20 or better in each eye
- Difference between cycloplegic and manifest refraction spherical equivalent ≤ 0.75 D
- Able and willing to return for scheduled follow-up after surgery
- Able to read, understand, and provide written informed consent and authorization as needed
You will not qualify if you...
- Pregnant, nursing, or planning pregnancy during the study, or conditions causing hormone fluctuations affecting vision
- Dry eye syndrome not controlled by medication or lubricants
- Serious acute, chronic, or systemic non-eye diseases increasing operative risk or affecting study completion
- Eye conditions other than high myopia that may cause complications (e.g., pigment dispersion, iritis, past eye surgery, monocular, corneal disease, retinal vascular disease, keratoconus, glaucoma, uncontrolled dry eye)
- Not qualifying for both bilateral Wavefront Optimized LASIK and bilateral EVO+ ICL implantation
- Emotional, physiological, or anatomical conditions preventing participation or proper treatment
- Participation in another ocular clinical trial within past 6 months
- Other conditions making subject unsuitable for treatment or study as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 5 locations
1
Kugler Vision
Omaha, Nebraska, United States, 68118
Not Yet Recruiting
2
Cleveland Eye Clinic
Cleveland, Ohio, United States, 44035
Not Yet Recruiting
3
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
4
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
5
Slade & Baker Vision
Houston, Texas, United States, 77027
Actively Recruiting
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Research Team
K
Kristin L Dunne
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument.
Ron D Hays, Carol M Mangione, Leon Ellwein...
https://pubmed.ncbi.nlm.nih.gov/14644710United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up.
Donald R Sanders, Kimberley Doney, Monica Poco...
https://pubmed.ncbi.nlm.nih.gov/15350323Refractive Outcomes After LASIK for the Treatment of Mixed Astigmatism with the Allegretto WaveLight EX500.
Majid Moshirfar, Kathryn Durnford, Alin Megerdichian...
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Huiyi Du, Bo Zhang, Zheng Wang...
https://pubmed.ncbi.nlm.nih.gov/37365492