Tilt and DecentrationNCT07218419
Comparison of Methods for Assessing Intraocular Lens Position
An observational study of Tilt and Decentration, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites in United States.
Trial summary
Prospective, multi-center, non-interventional, open label, clinical study. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tilt and Decentration
- What is being tested?
- IOL Decentration Assessment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Nov 2025to 16 Jan 2026
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants eligible for the study must be 22 years of age or older and have received a refractive or diffractive nontoric TECNIS IOL in at least one eye. Additionally, they must be at least three months post-operative in the designated study eye. The Investigator should choose the eye without any clinically significant medical conditions that may interfere with the evaluation of IOL tilt and decentration using the testing methods specified in this study. If both eyes meet the eligibility criteria, the right eye will be designated as the study eye.
Who may be able to join
- All criteria apply to study eye.
- The subject must:
- Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
- Appear capable and willing to adhere to the clinical protocol procedures.
- Be 22 years of age or older at the time of screening.
- Have undergone unilateral or bilateral implantation with a desired TECNIS non-toric IOL design (e.g., refractive or diffractive).
- Be at least three months postoperative in the study eye.
Who cannot join
- All criteria apply to study eye.
- The subject must NOT:
- Any medical or ocular history, in the opinion of the investigator, that may impact study procedures such as ocular trauma, pseudoexfoliation syndrome, retinal pigment degeneration, macular pathology, glaucoma, retinal disease, corneal disease, or corneal opacities.
- Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
- Have a history of corneal or intraocular surgery other than cataract surgery.
- Be using ocular or systemic medications known to interact with dilation drops.
Show all 13Show fewer
- Have a history of hypersensitivity, allergic reaction or other contraindication to dilation drops.
- Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
- Have an intraocular pressure of ≥ 21mm Hg before mydriasis.
- Have a mydriatic pupil diameter of less than 6mm.
- Have participated in clinical trial within 7 days prior to study enrollment.
- Be an employee (e.g., Investigator, Coordinator, or Technician) or immediate family member (including partner, child, parent, grandparent, grandchild, or sibling) of an employee of the clinical site or study sponsor.
- Be currently pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Empire Eye & Laser Center
Bakersfield, California, 93309
Jones Eye Center
Sioux City, Iowa, 51104
About this study
Prospective, multi-center, non-interventional, open label, clinical study.
Read the detailed description
The objective is to evaluate two methods for assessing IOL tilt and decentration in patients who have been unilaterally or bilaterally implanted with a refractive or diffractive nontoric TECNIS IOL before participating into this study. The agreement will be assessed between the decentration measurements derived from retro-illuminated slit lamp image analysis and those obtained from the subjective slit lamp grading method.
- Conditions
- Tilt and Decentration
- Being tested
- IOL Decentration Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL Decentration AssessmentDiagnostic test
Also called Basic Science
This study assesses two methods to measure IOL decentration. Each subject will be evaluated in only one eye with both methods for assessing IOL decentration:
(i) retro-illuminated slit lamp image analysis (objective slit lamp method) and (ii) subjective slit lamp grading method. There is no treatment or intervention on this study.
| Study group | Role | What they receive |
|---|---|---|
| IOL Decentration | The objective is to evaluate two methods for assessing IOL tilt and decentration in patients who have been unilaterally or bilaterally implanted with a refractive or diffractive non- toric TECNIS IOL before participating into this study. The agreement will be assessed between the decentration measurements derived from retro-illuminated slit lamp image analysis and those obtained from the subjective slit lamp grading method. Receives: Diagnostic Test: IOL Decentration Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL Decentration
- Magnitude of Decentration relative to the center of the pupil.
- Direction of Decentration relative to the center of the pupil
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start3 Nov 2025
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tilt and DecentrationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Surgical Vision Inc. Johnson and Johnson, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218419
- Sponsor's protocol ID
- MDEV109TDMD
- Status last verified
- Mar 2026
- First submitted
- 7 Oct 2025
- Last updated
- 16 Mar 2026
- Results posted
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods for Assessing Intraocular Lens Position
- ClinicalTrials.gov ID
- NCT07218419
- Acronym / sponsor ID
- MDEV109TDMD
- Conditions
- Tilt and Decentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 20 Oct 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, multi-center, non-interventional, open label, clinical study.
Detailed description
The objective is to evaluate two methods for assessing IOL tilt and decentration in patients who have been unilaterally or bilaterally implanted with a refractive or diffractive nontoric TECNIS IOL before participating into this study. The agreement will be assessed between the decentration measurements derived from retro-illuminated slit lamp image analysis and those obtained from the subjective slit lamp grading method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOL Decentration | – | Diagnostic Test: IOL Decentration AssessmentThe objective is to evaluate two methods for assessing IOL tilt and decentration in patients who have been unilaterally or bilaterally implanted with a refractive or diffractive non- toric TECNIS IOL before participating into this study. The agreement will be assessed between the decentration measurements derived from retro-illuminated slit lamp image analysis and those obtained from the subjective slit lamp grading method. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants eligible for the study must be 22 years of age or older and have received a refractive or diffractive nontoric TECNIS IOL in at least one eye. Additionally, they must be at least three months post-operative in the designated study eye. The Investigator should choose the eye without any clinically significant medical conditions that may interfere with the evaluation of IOL tilt and decentration using the testing methods specified in this study. If both eyes meet the eligibility criteria, the right eye will be designated as the study eye.
Key inclusion criteria (7 listed)
- All criteria apply to study eye.
- Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
- Appear capable and willing to adhere to the clinical protocol procedures.
- Be 22 years of age or older at the time of screening.
- Have undergone unilateral or bilateral implantation with a desired TECNIS non-toric IOL design (e.g., refractive or diffractive).
Key exclusion criteria (13 listed)
- All criteria apply to study eye.
- Any medical or ocular history, in the opinion of the investigator, that may impact study procedures such as ocular trauma, pseudoexfoliation syndrome, retinal pigment degeneration, macular pathology, glaucoma, retinal disease, corneal disease, or corneal opacities.
- Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
- Have a history of corneal or intraocular surgery other than cataract surgery.
- Be using ocular or systemic medications known to interact with dilation drops.
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 |
|---|---|---|
| IOL Decentration AssessmentAlso: Basic ScienceThis study assesses two methods to measure IOL decentration. Each subject will be evaluated in only one eye with both methods for assessing IOL decentration: (i) retro-illuminated slit lamp image analysis (objective slit lamp method) and (ii) subjective slit lamp grading method. There is no treatment or intervention on this study. | Diagnostic test | IOL Decentration |
Primary outcome
IOL Decentration
Time frame: 3 months
* Magnitude of Decentration relative to the center of the pupil. * Direction of Decentration relative to the center of the pupil
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 16 Mar 2026.
- 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.
Related trials for Tilt and Decentration
Active, not recruiting
Impact of Capsular Tension Ring Implantation on Intraocular Lens Position
Cataract, High Myopia
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
RecruitingObservational study
Comparison of Two Different Methods for Calculating Intraocular Lens Tilt and Decentration
Intraocular Lens
Recruiting
Outcome of Two Surgical Methods for IOLImplantation in Eyes With Pseudoexfoliation Syndrome
Age Related Cataracts, Pseudoexfoliation Syndrome
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.
Surgical Vision Inc. Johnson and Johnson study director
Study Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tilt and Decentration, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites 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 7 inclusion and 13 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
IOL Decentration (time frame: 3 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 16 Mar 2026.