Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants

NCT07213167 | Recruiting FDA Device

• 1 other identifier: EMP-2025-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical investigation is to evaluate visual acuity and contrast sensitivity in low lighting conditions using several different testing devices, and measure nighttime side effects of intraocular lens (IOL) implants after cataract surgery. 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

Conditions

Dysphotopsia; Posterior Capsule Opacification; Visual Acuity; Visual Function; Contrast Sensitivity

Keywords

Dysphotopsia; Posterior Capsule Opacification; Halometry; Manifold Vision Meter; PRVSQ; AIOLIS; TECNIS Eyhance IOL; TECNIS Symfony Optiblue IOL; TECNIS Odyssey IOL; Low Contrast; Defocus Curves; Low Light Photic Phenomena; Dysphotopsia Profiles; Pseudophakia; TECNIS 1-Piece

Outcome Measures

Primary Outcomes (3)

• Low (50%) contrast defocus curve

  Measured low (50%) contrast defocus curve compared between all three groups

  Day 1

• Halometry assessment of photic phenomena

  Halometry assessment of halos and starbursts utilizing a cool white light with varying intensities. Comparing the measured size of the ring (deg) of each condition between all three groups.

  Day 1

• PRVSQv2 questionnaire results

  PRVSQv2 questionnaire results compared between all three groups: Frequency and bother/severity of symptoms (scale 1 to 5, with 5 most bothersome)

  Day 1

Secondary Outcomes (9)

• Best corrected distance visual acuity (BCDVA)

  Day 1

• Low contrast (50%) BCDVA

  Day 1

• Contrast Sensitivity

  Day 1

• High Contrast Defocus Curve

  Day 1

• Halometry

  Day 1

Study Arms (3)

Tecnis Monofocals

Pseudophakic subjects with Tecnis Monofocals, Models ZCB00, ZCUxxx, DIB00, GIB00, and DIUxxx intraocular lenses.

Other: None-placebo

Tecnis Symfony Optiblue

Pseudophakic subjects with Tecnis Symfony Optiblue, model ZXR00V, ZXWxxx intraocular lenses.

Other: None-placebo

Tecnis Odyssey

Pseudophakic subjects with Tecnis Odyssey, model DRN00V, DRTxxx intraocular lenses.

Other: None-placebo

Interventions

None-placebo OTHER

No interventions, only post-market, post-implantation observation.

Tecnis Monofocals; Tecnis Odyssey; Tecnis Symfony Optiblue

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bilateral pseudophakia, at least 3 months postoperative from IOL implantation with one of the study IOL models.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Daniel H. Chang, MD: lead
• Johnson & Johnson Surgical Vision, Inc.: collaborator

Study Sites (1)

Empire Eye and Laser Center

Bakersfield, California, 93309, United States

RECRUITING

MeSH Terms

Conditions

Pseudophakia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel H Chang, MD

  Empire Eye and Laser Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany M Camirand

CONTACT

661-301-6211; bcamirand@empireeyeandlaser.com

Daniel H Chang, MD

CONTACT

661-325-3937; dchang@empireeyeandlaser.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 8, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)