Joint Warfighter Refractive Surgery Center at WHASC
San Antonio, Texas, 78236, United States
NCT Number: NCT07128316
Participants will undergo LASIK using Contoura with Phorcides calculation on one eye and LASIK using iDesign calculation on the contralateral eye to correct myopia.
This study is active but is not currently recruiting participants.
21 year–50 year
All sexes
Interventional
Not applicable
San Antonio, Texas, 78236, United States
Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo LASIK using Contoura with Phorcides calculation on one eye and LASIK using iDesign calculation on the contralateral eye to correct myopia. The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using Contoura with Phorcides calculation vs. LASIK using iDesign calculation. Surgical treatment will be randomized so there is a 50% chance to receive LASIK using Contoura with Phorcides vs LASIK using iDesign calculation on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. This will be a prospective randomized double blind contralateral study. The patient and the staff doing the post-op evaluations will be blinded to which eye received which treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LASIK calculated ablation using Contoura Topolyzer with Phorcides
LASIK calculated ablation using iDesign Refractive Studio 2.0
Time frame: 6-month Post-Op
Post-operative uncorrected visual acuity of 20/16 or better measure with ETDRS chart; unit = percentage eyes with Uncorrected Visual Acuity.
Time frame: Change from baseline (pre-op) to 6-month Post-Op
Change in the mean uncorrected visual acuity (unit = logMAR) measure with ETDRS chart from baseline (pre-op) at 6 months post-op.
Time frame: Change from baseline (pre-op) to 6-month Post-Op
Change in the mean refractive error measure with phoropter (unit = diopters) from baseline (pre-op) at 6 months post-op.
Time frame: Change from baseline (pre-op) to 6-month Post-Op
Change in the mean low contrast visual acuity (unit = logMAR) measure with ETDRS 5% chart from baseline (pre-op) at 6 months post-op.
Time frame: Change from baseline (pre-op) to 6-month Post-Op
Change in the mean higher order aberrations (unit = root mean square) measure with iDesign 2.0 Refractive Studio from baseline (pre-op) at 6 months post-op.
Time frame: Change from baseline (pre-op) to 6-month Post-Op
The PROWL-SS is a validated tool to assess self-reported symptoms and satisfaction after refractive surgery. Possible Satisfaction Score ranges from 1 (completely satisfied) to 6 (completely dissatisfied). Lower value indicates higher satisfaction. Possible Symptoms Score ranges from 1 (extremely bothersome) to 5 (not at all bothersome). Lower value indicates worse symptoms.
Time frame: Change from baseline (pre-op) to 6-month Post-Op
The SPEED is a validated tool to assess self-reported dry eye symptoms. Possible dry eye symptoms score ranges from 0 (never) to 3 (Constant). Higher value indicates worse dry eye symptoms.
59th Medical Wing
Fed
Comparison of Clinical Outcomes of LASIK Using Contoura With Phorcides vs. iDesign
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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