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Light-Adjustable Lens for Cataract
N/A
Recruiting
Led By Clayton G Blehm, MD
Research Sponsored by Gainesville Eye Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months postop
Awards & highlights
Study Summary
This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months postop
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months postop
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Binocular corrected distance visual acuity (CDVA)
Secondary outcome measures
Binocular distance corrected intermediate visual acuity (DCIVA)
Binocular uncorrected distance visual acuity (UDVA)
Binocular uncorrected intermediate visual acuity (UIVA)
+4 moreOther outcome measures
Binocular distance corrected defocus curve
Binocular distance-corrected near visual acuity (DCNVA)
Binocular uncorrected near visual acuity (UNVA)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Light-Adjustable LensExperimental Treatment1 Intervention
Group II: Clareon MonofocalExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Gainesville Eye AssociatesLead Sponsor
5 Previous Clinical Trials
149 Total Patients Enrolled
4 Trials studying Cataract
131 Patients Enrolled for Cataract
SengiIndustry Sponsor
19 Previous Clinical Trials
1,455 Total Patients Enrolled
11 Trials studying Cataract
973 Patients Enrolled for Cataract
Clayton G Blehm, MDPrincipal InvestigatorGainesville Eye Associates
3 Previous Clinical Trials
100 Total Patients Enrolled
3 Trials studying Cataract
100 Patients Enrolled for Cataract
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