Measurement of Refractive ErrorNCT06797856
Measurement of Refractive Error in Pseudophakic Eyes Using an Autorefractor and a Wavefront Aberrometer
An observational study of Measurement of Refractive Error, run by Johnson & Johnson Surgical Vision, Inc. at 1 site in United States.
Trial summary
Prospective, single-site, non-interventional, technician masked, randomized (instrument and examiner testing sequences), controlled, bilateral, parallel-group study. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Measurement of Refractive Error
- What is being tested?
- Refractive Error
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2025to 9 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, single-site, non-interventional, technician masked, randomized (instrument and examiner testing sequences), controlled, bilateral, parallel-group study.
- Conditions
- Measurement of Refractive Error
- Being tested
- Refractive Error
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refractive ErrorDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Refractive Error |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two study visits, 1 to 14 calendar days apart. Study duration approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start17 Feb 2025
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measurement of Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797856
- Sponsor's protocol ID
- MDEV112ARGS
- Status last verified
- Jul 2025
- First submitted
- 27 Jan 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Refractive Error in Pseudophakic Eyes Using an Autorefractor and a Wavefront Aberrometer
- ClinicalTrials.gov ID
- NCT06797856
- Acronym / sponsor ID
- MDEV112ARGS
- Conditions
- Measurement of Refractive Error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single-site, non-interventional, technician masked, randomized (instrument and examiner testing sequences), controlled, bilateral, parallel-group study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractive Error | – | 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Refractive Error
Time frame: Two study visits, 1 to 14 calendar days apart. Study duration approximately 6 months.
* 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measurement of Refractive Error, run by Johnson & Johnson Surgical Vision, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive Error (time frame: Two study visits, 1 to 14 calendar days apart. Study duration approximately 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.