Night and low-contrast vision with three types of intraocular lenses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares visual function and nighttime photic phenomena across three commonly used intraocular lens (IOL) models using device-based tests and patient questionnaires. Participants complete two vision questionnaires (PRVSQ v2 and AIOLIS in randomized order) and undergo a battery of tests including low- and high-contrast defocus curves, halometry at multiple light levels and colors, contrast sensitivity, pupilometry, and standard acuity and slit-lamp exams. Primary endpoints are the 50% low-contrast defocus curve, objective halometry measurements under cool white light, and PRVSQv2 results, with secondary outcomes covering a wide set of visual performance and satisfaction measures. The study enrolls adults at least three months after bilateral IOL implantation and aims to correlate objective device measures with patient-reported symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Minimum 22 years of age
* 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:

* Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils.
* 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

Where it's running

• Empire Eye and Laser Center
  Bakersfield, California, United States Recruiting

Study contacts

• Principal investigator: Daniel H Chang, MD — Empire Eye and Laser Center
• Study coordinator: Brittany M Camirand
• Email: bcamirand@empireeyeandlaser.com
• Phone: 661-301-6211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.