Recruiting

IOL Comparison

Sponsor:

Dr. Daniel H. Chang, MD

Code:

NCT07213167

Conditions

Dysphotopsia

Posterior Capsule Opacification

Visual Acuity

Visual Function

Contrast Sensitivity

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

None-placebo

Study Details

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

Study ID

NCT07213167

Start date

Sep 24, 2025

Status verified date

Oct, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Tecnis Monofocals

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

Tecnis Symfony Optiblue

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

Tecnis Odyssey

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

Interventions

None-placebo

No interventions.

Primary outcome measure

  • Low (50%) contrast defocus curve [ Time Frame: Day 1 ]
  • Halometry assessment of photic phenomena [ Time Frame: Day 1 ]
  • PRVSQv2 questionnaire results [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Brittany M Camirand

661-301-6211bcamirand@empireeyeandlaser.com

Daniel H Chang, MD

661-325-3937dchang@empireeyeandlaser.com

Locations

Empire Eye and Laser Center

Recruiting

Bakersfield, California, United States, 93309

Contacts

Brittany M Camirand

661-301-6211bcamirand@empireeyeandlaser.com

Research Department

661-325-3937

Principal Investigator:

Daniel H Chang, MD

More Information

Sponsor

Dr. Daniel H. Chang, MD

Last update posted

Apr 6, 2026

Last verified

Oct, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Daniel H. Chang, MD on 2026-04-06.