DysphotopsiaNCT07213167
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
An observational study of Dysphotopsia and Posterior Capsule Opacification, run by Dr. Daniel H. Chang, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Dysphotopsia, Posterior Capsule Opacification, Visual Acuity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bilateral pseudophakia, at least 3 months postoperative from IOL implantation with one of the study IOL models.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Empire Eye and Laser Center
Bakersfield, California, 93309
Brittany M Camirand, 661-301-6211, bcamirand@empireeyeandlaser.com
Research Department, 661-325-3937 ext. 203
About this study
Official title: Clinical Evaluation of Low Contrast Defocus Curves, Low Light Photic Phenomena, and Dysphotopsia Profiles in Pseudophakic Patients
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
- Conditions
- Dysphotopsia, Posterior Capsule Opacification, Visual Acuity, Visual Function, Contrast Sensitivity
- Being tested
- None-placebo
- 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
- Medical subject headings
- Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-placeboOther
No interventions, only post-market, post-implantation observation.
| Study group | Role | What they receive |
|---|---|---|
| Tecnis Monofocals | Pseudophakic subjects with Tecnis Monofocals, Models ZCB00, ZCUxxx, DIB00, GIB00, and DIUxxx intraocular lenses. Receives: Other: None-placebo | |
| Tecnis Symfony Optiblue | Pseudophakic subjects with Tecnis Symfony Optiblue, model ZXR00V, ZXWxxx intraocular lenses. Receives: Other: None-placebo | |
| Tecnis Odyssey | Pseudophakic subjects with Tecnis Odyssey, model DRN00V, DRTxxx intraocular lenses. Receives: Other: None-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low (50%) contrast defocus curve
Measured low (50%) contrast defocus curve compared between all three groups
Measured: 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.
Measured: 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)
Measured: Day 1
Secondary outcomes (9)
Best corrected distance visual acuity (BCDVA)
Best corrected distance visual acuity (BCDVA) compared between all three groups
Measured: Day 1
Low contrast (50%) BCDVA
Low contrast (50%) BCDVA compared between all three groups
Measured: Day 1
Contrast Sensitivity
Contrast sensitivity compared between all three groups
Measured: Day 1
High Contrast Defocus Curve
High Contrast Defocus Curve compared between all three groups
Measured: Day 1
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.
Measured: Day 1
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)
Measured: Day 1
Pupil Size
Photopic and mesopic pupil size compared between all three study groups
Measured: Day 1
YAG Capsulotomies
Number of YAG capsulotomies performed within one year post-op compared between all three groups
Measured: Day 1
Posterior capsular opacification (PCO)
Pre-planned post-hoc analysis evaluating number of participants with and without PCO compared between all three groups
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start24 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphotopsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dr. Daniel H. Chang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Responsible party
- Sponsor-investigator, Dr. Daniel H. Chang, MD, Empire Eye and Laser Center
- Investigators
- Daniel H Chang, MD, Principal investigator, Empire Eye and Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213167
- Sponsor's protocol ID
- EMP-2025-001
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No