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CompletedNCT06797856Updated Jul 23, 2025

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

An observational study in Measurement of Refractive Error, sponsored by Johnson & Johnson Surgical Vision, Inc.. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Johnson & Johnson Surgical Vision, Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
46
Ages
40 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Measurement of Refractive Error
03

In context

Lead sponsor

Johnson & Johnson Surgical Vision, Inc. is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 13 (87%) have results posted.

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

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
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).

Eligibility criteria

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
46 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testRefractive 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Two study visits, 1 to 14 calendar days apart. Study duration approximately 6 months.

07

Study locations

1 site
  • SoCal Eye
    Long Beach, California 90805, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06797856
Lead sponsor
Johnson & Johnson Surgical Vision, Inc.
Responsible party
Sponsor
First posted
Jan 29, 2025
Start date
Feb 17, 2025
Primary completion
Jul 9, 2025
Completion
Jul 9, 2025
Last update
Jul 23, 2025

Oversight

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

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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