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RecruitingNCT07213167Updated Sep 25, 2026

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

An observational study in Dysphotopsia, Posterior Capsule Opacification and Visual Acuity, sponsored by Dr. Daniel H. Chang, MD. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Dr. Daniel H. Chang, MD · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Updated Sep 25, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
22 Years and older
Sex
All
01

Study 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
Read the detailed description

The purpose of the study is to correlate the low contrast defocus curves, objective halometry measurement of low light photic phenomena, and patient reported dysphotopsia profiles of the various study IOLs.

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
02

Conditions studied

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

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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
03

In context

Pseudophakia

54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.

This study's planned enrollment of 120 is above the median of 71 across 26 observational studies indexed under Pseudophakia.

Browse Pseudophakia studies →

Lead sponsor

Dr. Daniel H. Chang, MD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Any 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherNone-placebo

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

06

What researchers measure

Primary outcomes

  1. Low (50%) contrast defocus curve

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

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

  3. 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)

    Time frame: Day 1

Secondary outcomes

  1. Best corrected distance visual acuity (BCDVA)

    Best corrected distance visual acuity (BCDVA) compared between all three groups

    Time frame: Day 1

  2. Low contrast (50%) BCDVA

    Low contrast (50%) BCDVA compared between all three groups

    Time frame: Day 1

  3. Contrast Sensitivity

    Contrast sensitivity compared between all three groups

    Time frame: Day 1

  4. High Contrast Defocus Curve

    High Contrast Defocus Curve compared between all three groups

    Time frame: Day 1

  5. Halometry

    Halometry assessment of halos and starbursts utilizing various light colors (cool white, warm white, red, yellow, and green) and intensities. Comparing the measured size of the ring (deg) of each condition between all three groups.

    Time frame: Day 1

  6. Patient-Reported Outcome (PRO) Questionnaires

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

    Time frame: Day 1

  7. Pupil Size

    Photopic and mesopic pupil size compared between all three study groups

    Time frame: Day 1

  8. YAG Capsulotomies

    Number of YAG capsulotomies performed within one year post-op compared between all three groups

    Time frame: Day 1

  9. Posterior capsular opacification (PCO)

    Pre-planned post-hoc analysis evaluating number of participants with and without PCO compared between all three groups

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • Empire Eye and Laser Center
    Bakersfield, California 93309, United States
    Recruiting
    • Brittany M Camirand · Contactbcamirand@empireeyeandlaser.com · 661-301-6211
    • Research Department · Contact661-325-3937
    • Daniel H Chang, MD · Principal investigator
    • Andrew A Kao, MD · Sub investigator
    • Laura K Huggins, OD · Sub investigator
    • Jacqueline N Albert, OD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Jul 2026→Dec 2026
Sep 25, 2026
Study completion
Aug 2026→Dec 2026
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Primary completion Jul 2026→Dec 2026
    Study completion Aug 2026→Dec 2026
    + 2 other changes: verification date and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07213167
Lead sponsor
Dr. Daniel H. Chang, MD
Responsible party
Dr. Daniel H. Chang, MD (Principal Investigator, Empire Eye and Laser Center) — Sponsor-investigator
First posted
Oct 8, 2025
Start date
Sep 24, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 25, 2026

Study contacts

Brittany M Camirand
Contact
bcamirand@empireeyeandlaser.com
661-301-6211
Daniel H Chang, MD
Contact
dchang@empireeyeandlaser.com
661-325-3937
Daniel H Chang, MD
principal investigator · Empire Eye and Laser Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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