Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
NCT ID: NCT07213167
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-09-24
2026-03-31
Brief Summary
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Researchers will compare the results for three different types of IOLs to see how each lens contributes to overall visual function, patient experience and satisfaction.
Participants will:
* Complete two different questionnaires about their current vision
* Undergo visual testing using several different devices
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Detailed Description
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The primary endpoints are low (50%) contrast defocus curve, halometry (cool white light) assessment of photic phenomena, and PRVSQv2 results.
The secondary endpoints are:
* Visual Acuity
* BCDVA
* Low contrast (50%) BCDVA
* Contrast Sensitivity
* High contrast defocus curve
* Halometry:
* Light levels: low, medium, high
* Colors: cool white, warm white, red, green
* Characterization of glare, starbursts, and halos
* PRO questionnaires
* AIOLIS
* Patient satisfaction and recommendation survey
* Pupil size
* YAG capsulotomy within 1 year
* Posterior capsular opacification: pre-planned post-hoc analysis evaluating performance in patients w/wo PCO Monocular BCDVA
Participants will:
* Complete PRVSQ v2 and AIOLIS vision questionnaires in a randomized order.
* Undergo the following visual testing using M\&S, clinical halometry, and the manifold vision meter devices:
* Manifest refraction
* Distance visual acuity
* Defocus testing
* Low contrast testing
* Contrast sensitivity
* Pupilometry
* Halometry
* Biomicroscopic slit-lamp exam
* Intraocular pressure
* Non-directed ocular symptoms
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Tecnis Eyhance
Pseudophakic subjects with Tecnis Eyhance, model DIB00, DIUxxx intraocular lenses.
None-placebo
No interventions.
Tecnis Symfony Optiblue
Pseudophakic subjects with Tecnis Symfony Optiblue, model ZXR00V, ZXWxxx intraocular lenses.
None-placebo
No interventions.
Tecnis Odyssey
Pseudophakic subjects with Tecnis Odyssey, model DRN00V, DRTxxx intraocular lenses.
None-placebo
No interventions.
Interventions
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None-placebo
No interventions.
Eligibility Criteria
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Inclusion Criteria
* Bilateral pseudophakia, at least 3 months postoperative from IOL implantation, with one of the study IOL models in at least one eye.
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
* Ability to understand and respond to a questionnaire in English
Exclusion Criteria
* Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
* Uncorrected distance visual acuity worse than 20/25 in either eye
* Prior corneal refractive surgery (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcomes are acceptable.
* Posterior capsular opacification with grading worse than 1+
* Ocular findings that may, in the opinion of the investigator, affect vision and/or contrast sensitivity
22 Years
ALL
No
Sponsors
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Johnson & Johnson Surgical Vision, Inc.
INDUSTRY
Dr. Daniel H. Chang, MD
OTHER
Responsible Party
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Dr. Daniel H. Chang, MD
Principal Investigator
Principal Investigators
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Daniel H Chang, MD
Role: PRINCIPAL_INVESTIGATOR
Empire Eye and Laser Center
Locations
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Empire Eye and Laser Center
Bakersfield, California, United States
Countries
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Central Contacts
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Facility Contacts
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Research Department
Role: backup
Other Identifiers
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EMP-2025-001
Identifier Type: -
Identifier Source: org_study_id
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