PresbyopiaNCT04474782
Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients
An observational study of Presbyopia, run by Vance Thompson Vision at 1 site in United States.
Trial summary
Educating patients on visual performance with presbyopic correcting intraocular lenses is crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic crystalline lens will provide eye care provides useful information to better educate patients on visual performance expectations after cataract… Read more about this study
- Who is it for?
- Ages 37 to 48 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- There is not an intervention
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2019to 31 Aug 2020
- How long will I take part?
- 1 Day
- 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 37 to 48 years
- All sexes
- Adult
Study population: A population of 30-60 subjects will be selected for testing. Subjects can be male or female, ages 37-48.
Who may be able to join
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
- 37-48 years of age
- Phakic
Who cannot join
- Previous cataract surgery
- Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
- Subjects that are unable to obtain 20/20 BCVA (i.e. amblyopia, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Educating patients on visual performance with presbyopic correcting intraocular lenses is crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic crystalline lens will provide eye care provides useful information to better educate patients on visual performance expectations after cataract surgery with a presbyopic correcting intraocular lens. Our objective will be to assess the subjective range of clear vision of a pre-presbyopic and emerging presbyopic patient population utilizing a defocus curve. A comparison of the pre-presbyopic and emerging presbyopic defocus curve to all FDA-approved presbyopic intraocular lenses will be discussed in the manuscript.
- Conditions
- Presbyopia
- Being tested
- There is not an intervention
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is not an interventionDiagnostic test
There is not an intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LogMar visual acuity during vision testing on ETDRS with loose lenses
Measured: Screening/enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start17 Oct 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- 45 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474782
- Sponsor's protocol ID
- VT-2019-01
- Status last verified
- Mar 2021
- First submitted
- 7 Jul 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients
- ClinicalTrials.gov ID
- NCT04474782
- Acronym / sponsor ID
- VT-2019-01
- Conditions
- Presbyopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 17 Jul 2020 (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.
Educating patients on visual performance with presbyopic correcting intraocular lenses is crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic crystalline lens will provide eye care provides useful information to better educate patients on visual performance expectations after cataract surgery with a presbyopic correcting intraocular lens. Our objective will be to assess the subjective range of clear vision of a pre-presbyopic and emerging presbyopic patient population utilizing a defocus curve. A comparison of the pre-presbyopic and emerging presbyopic defocus curve to all FDA-approved presbyopic intraocular lenses will be discussed in the manuscript.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 37 to 48 years
- Sex
- All
- Age groups
- Adult
- Study population
- A population of 30-60 subjects will be selected for testing. Subjects can be male or female, ages 37-48.
Key inclusion criteria (3 listed)
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
- 37-48 years of age
- Phakic
Key exclusion criteria (3 listed)
- Previous cataract surgery
- Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
- Subjects that are unable to obtain 20/20 BCVA (i.e. amblyopia, etc.)
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 |
|---|---|---|
| There is not an interventionThere is not an intervention | Diagnostic test | – |
Primary outcome
Change in LogMar visual acuity during vision testing on ETDRS with loose lenses
Time frame: Screening/enrollment visit
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 30 Mar 2021.
- Individual participant dataSharing planned: No
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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 Presbyopia, run by Vance Thompson Vision 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 3 inclusion and 3 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 30 Mar 2021. 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?
Change in LogMar visual acuity during vision testing on ETDRS with loose lenses (time frame: Screening/enrollment visit). 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 30 Mar 2021.