CataractNCT03819842
Evaluating the Need for the Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation
A study testing Pseudophakic Measurement in people with Cataract and Nuclear Sclerosis, run by Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons at 1 site in United States.
Trial summary
To determine clinically significant difference in results obtained from cataract surgery using IA. One eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric IOL. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Nuclear Sclerosis, Cortical Cataract
- What is being tested?
- Pseudophakic Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 14 Jan 2019
- Phase
- Interventional
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willing and able to understand and sign an informed consent
- willing and able to attend all study visits
- presenting for uncomplicated bilateral cataract surgery and have an interest in a toric iol
- have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)
- have visually significant cataracts
- have regular corneal astigmatism of 1.0D to 5.0D in both eyes with a difference between eyes of 1.0D or less
- have potential post operative acuity of 20/25 or better
Who cannot join
- corneal pathology
- amblyopia
- prior corneal refractive surgery or other refractive surgery
- previous anterior or posterior chamber surgery that the investigator feels may compromise visual outcomes
- Diabetic retinopathy if the investigator feels this will compromise visual outcomes
- macular degeneration
Show all 11Show fewer
- history of retinal detachment
- irregular astigmatism or keratoconus
- strabismus
- if in the surgeon's opinion the subject is not an appropriate candidate for iol implantation
- subjects who have an acute or chronic disease or illness that would confound the results of this investigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Alterman Modi and Wolter Ophthalmic Physicians and Surgeons
Poughkeepsie, New York, 12603
About this study
Official title: Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation
To determine clinically significant difference in results obtained from cataract surgery using IA. One eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric IOL.
Read the detailed description
To determine if there is a clinically significant difference in the results obtained for the toric IOL implantation when using IA to measure the aphakic eye only and when using IA to measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.
- Conditions
- Cataract, Nuclear Sclerosis, Cortical Cataract, Posterior Subcapsular Cataract, Astigmatism
- Being tested
- Pseudophakic Measurement
- Keywords
- cataract surgery, cataract, toric IOL
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pseudophakic MeasurementDiagnostic test
standard aphakic measurements will be taken and then pseudophakic measurements will be taken after toric iol implantation. The data produced will aid the surgeon in proper placement of toric iol orientation
| Study group | Role | What they receive |
|---|---|---|
| Aphakic Measure only | No intervention | Eye measured in aphakic state only |
| Pseudophakic measure | Active comparator | Eye measured in aphakic state then again in pseudophakic state with toric IOL using the ORA System. Pseudophakic measurement obtained will provide data about placement of toric iol and the surgeon will use that data to rotate the iol if necessary. Receives: Diagnostic Test: Pseudophakic Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant difference in results obtained for tori iol implantation when using IA
Difference in magnitude of residual refractive astigmatism between groups Percentage of eyes with 0.50D or less of postoperative residual refractive astigmatism at 1 month post-op in each sub-group
- Percentage of eyes within 0.50D of intended spherical equivalent
- Sub-group analysis:
- Vector analysis of the effects of any toric IOL realignment suggested by pseudophakic IA (i.e. was it likely to improve or worsen residual refractive astigmatism and/or UCVA)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start19 Mar 2018
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819842
- Sponsor's protocol ID
- SSM--2017-12
- Status last verified
- Jan 2022
- First submitted
- 22 Jan 2019
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Results of the study may be shared at international meetings and submitted for peer review
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation
- ClinicalTrials.gov ID
- NCT03819842
- Acronym / sponsor ID
- SSM--2017-12
- Conditions
- Cataract, Nuclear Sclerosis, Cortical Cataract, Posterior Subcapsular Cataract, Astigmatism
- Keywords
- cataract surgery, cataract, toric IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alterman, Modi, & Wolter Ophthalmic Physicians & SurgeonsUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 29 Jan 2019 (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.
To determine clinically significant difference in results obtained from cataract surgery using IA. One eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric IOL.
Detailed description
To determine if there is a clinically significant difference in the results obtained for the toric IOL implantation when using IA to measure the aphakic eye only and when using IA to measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aphakic Measure only | No intervention | –Eye measured in aphakic state only |
| Pseudophakic measure | Active comparator | Diagnostic Test: Pseudophakic MeasurementEye measured in aphakic state then again in pseudophakic state with toric IOL using the ORA System. Pseudophakic measurement obtained will provide data about placement of toric iol and the surgeon will use that data to rotate the iol if necessary. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- willing and able to understand and sign an informed consent
- willing and able to attend all study visits
- presenting for uncomplicated bilateral cataract surgery and have an interest in a toric iol
- have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)
- have visually significant cataracts
Key exclusion criteria (11 listed)
- corneal pathology
- amblyopia
- prior corneal refractive surgery or other refractive surgery
- previous anterior or posterior chamber surgery that the investigator feels may compromise visual outcomes
- Diabetic retinopathy if the investigator feels this will compromise visual outcomes
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 |
|---|---|---|
| Pseudophakic Measurementstandard aphakic measurements will be taken and then pseudophakic measurements will be taken after toric iol implantation. The data produced will aid the surgeon in proper placement of toric iol orientation | Diagnostic test | Pseudophakic measure |
Primary outcome
Clinically significant difference in results obtained for tori iol implantation when using IA
Time frame: 30 days
Difference in magnitude of residual refractive astigmatism between groups Percentage of eyes with 0.50D or less of postoperative residual refractive astigmatism at 1 month post-op in each sub-group * Percentage of eyes within 0.50D of intended spherical equivalent * Sub-group analysis: * Vector analysis of the effects of any toric IOL realignment suggested by pseudophakic IA (i.e. was it likely to improve or worsen residual refractive astigmatism and/or UCVA)
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 20 Jan 2022.
- Individual participant dataSharing planned: Undecided. Results of the study may be shared at international meetings and submitted for peer review
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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?
A study testing Pseudophakic Measurement in people with Cataract and Nuclear Sclerosis, run by Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons 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 7 inclusion and 11 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 20 Jan 2022. 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?
Clinically significant difference in results obtained for tori iol implantation when using IA (time frame: 30 days). 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 20 Jan 2022.