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

NCT06797856 | Completed FDA Device

• 1 other identifier: MDEV112ARGS
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Measurement of Refractive Error

Outcome Measures

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

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

Study Arms (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

Diagnostic Test: Refractive Error

Interventions

Refractive Error DIAGNOSTIC_TEST

* 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

Refractive Error

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• The subject must:
• Read, understand, and sign the Statement of Informed Consent and HIPAA authorization and receive a fully executed copy of the form(s).
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be 40 years of age or older at the time of enrollment.
• 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).
• 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.
• The subject must:
• In the study eye, meet the following criteria with regard to the non-vertex-corrected (i.e., spectacleplane) distance subjective refraction:
• Mean spherical equivalent must be between +2.00 and -2.00 DS (inclusive).
• The magnitude of the cylinder must be 1.50 DC or less.
• Have best-corrected visual acuity of at least 20/32 in the study eye.

You may not qualify if:

• The subject must not:
• Be pregnant.
• Have uncontrolled diabetes by self-report.
• Have a history of ocular trauma, systemic disease or medication use known to cause variability in refractive error.
• 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.
• Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, scleral lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months.
• 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.
• Be taking any ocular or systemic medications known to adversely affect vision or cause miosis, or that may otherwise compromise study endpoints.
• The subject must not:
• 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).
• 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.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (1)

SoCal Eye

Long Beach, California, 90805, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 29, 2025
• Study Start: February 17, 2025
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)