Measuring vision correction in eyes with artificial lenses

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

This study is testing new ways to measure vision in people over 40 who have had eye surgery to see if it can help improve how well artificial lenses work.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Johnson & Johnson Surgical Vision, Inc. (Industry-sponsored)
• Locations: 1 site (Long Beach, California)
• Trial ID: NCT06797856 on ClinicalTrials.gov

What this trial studies

This observational study aims to measure refractive error in pseudophakic eyes using advanced instruments like an autorefractor and a wavefront aberrometer. It is a prospective, single-site, non-interventional study where participants will undergo randomized testing sequences to evaluate the accuracy of these measurement techniques. The study focuses on individuals who have had intraocular lens (IOL) surgery and are at least 40 years old, ensuring that the refraction in their study eye has stabilized. The goal is to gather data that could improve vision correction methods for patients with artificial lenses.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 and older who have undergone IOL surgery and have a stable refraction in at least one pseudophakic eye.

Not a fit: Patients who have not had IOL surgery or are younger than 40 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the precision of vision correction for patients with pseudophakic eyes, leading to better visual outcomes.

How similar studies have performed: While similar studies have explored refractive error measurement techniques, this specific approach using both autorefractor and wavefront aberrometer in pseudophakic eyes is relatively novel.

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.

Where this trial is running

Long Beach, California

• SoCal Eye — Long Beach, California, United States (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Measurement of Refractive Error