Measurement of Refractive Error in Pseudophakic Eyes Using an Autorefractor and a Wavefront Aberrometer

Prospective, single-site, non-interventional, technician masked, randomized (instrument and examiner testing sequences), controlled, bilateral, parallel-group study.

Study Overview

• Status: Completed
• Conditions: Measurement of Refractive Error
• Intervention / Treatment: Diagnostic test: Refractive Error

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90805
      • SoCal Eye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects 40 years of age or older who have been bilaterally implanted with either the TECNIS® Eyhance™ IOL (model ICB00, GIB00 or DIB00) or the TECNIS® Monofocal 1-Piece IOL (model ZCB00 or DCB00).

Description

Inclusion Criteria following Screening

The subject must:

1. Read, understand, and sign the Statement of Informed Consent and HIPAA authorization and receive a fully executed copy of the form(s).
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be 40 years of age or older at the time of enrollment.
4. Be pseudophakic in at least one eye, with that eye (hereafter referred to as the 'study eye') implanted with either the TECNIS Eyhance™ IOL (model ICB00, GIB00 or DIB00) or the TECNIS® Monofocal 1-Piece IOL (model ZCB00 or DCB00).

5. Have had IOL surgery for the study eye completed at least 3 months prior to enrollment, with enough time elapsed between surgery and enrollment such that the refraction has stabilized in that eye.

   Inclusion Criteria at Baseline Evaluation

   The subject must:

6. In the study eye, meet the following criteria with regard to the non-vertex-corrected (i.e., spectacleplane) distance subjective refraction:

   1. Mean spherical equivalent must be between +2.00 and -2.00 DS (inclusive).
   2. The magnitude of the cylinder must be 1.50 DC or less.
7. Have best-corrected visual acuity of at least 20/32 in the study eye.

Exclusion Criteria following Screening

The subject must not:

1. Be pregnant.
2. Have uncontrolled diabetes by self-report.
3. Have a history of ocular trauma, systemic disease or medication use known to cause variability in refractive error.
4. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.) other than bilateral cataract surgery with IOL implantation and YAG laser capsulotomy.
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, scleral lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months.
6. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site or study Sponsor.
7. Be taking any ocular or systemic medications known to adversely affect vision or cause miosis, or that may otherwise compromise study endpoints.

8. Be currently participating in or have participated in any other clinical trial within 30 days prior to enrollment. Exclusion Criteria at Baseline Evaluation

   The subject must not:

9. Have clinically significant slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that, in the opinion of the investigator, may compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, corneal scar or opacity ≥ 0.3 mm, recurrent corneal erosions, moderate or above corneal distortion, herpetic keratitis).
10. Have posterior capsular opacification (PCO) that, in the opinion of the investigator, is significant enough that it is likely to detrimentally affect autorefraction or wavefront measurements. 11. Have fluctuations in vision due to clinically significant dry eye. 12. Have a history of strabismus, amblyopia, nystagmus, or any condition that affects fixation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Refractive Error; Refractive error centrally (on-axis) and peripherally in both nasal and temporal visual fields; Ocular wavefront measured centrally (on-axis) and peripherally in both nasal and temporal visual fields	Diagnostic test: Refractive Error; Refractive error centrally (on-axis) and peripherally in both nasal and temporal visual fields; Ocular wavefront measured centrally (on-axis) and peripherally in both nasal and temporal visual fields

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive Error	Refractive error centrally (on-axis) and peripherally in both nasal and temporal visual fields; Ocular wavefront measured centrally (on-axis) and peripherally in both nasal and temporal visual fields	Two study visits, 1 to 14 calendar days apart. Study duration approximately 6 months.

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Actual): July 9, 2025
• Study Completion (Actual): July 9, 2025

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: MDEV112ARGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes