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

NCT ID: NCT06797856

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2025-07-09

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Refractive Error

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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.

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

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.

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SoCal Eye

Long Beach, California, United States

Countries

United States

Other Identifiers

MDEV112ARGS

Identifier Type: -

Identifier Source: org_study_id