CataractsNCT00845520
Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)
A study testing Lens implantation +1.00 D postop target, Lens implantation -1.00 D postop target and Lens implantation 0.00 D postop target in people with Cataracts, run by Calhoun Vision, Inc. at 6 sites in 2 countries.
Trial summary
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataracts
- What is being tested?
- Lens implantation +1.00 D postop target, Lens implantation -1.00 D postop target and Lens implantation 0.00 D postop target
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by keratometry.
- Adults between the ages of 40 and 80 inclusive.
- Cataract causing reduction in best spectacle-corrected visual acuity to a level of 20/32 or worse.
- Best corrected visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/25 or better after cataract removal and IOL implantation.
- Clear intraocular media other than cataract.
- Potentially good vision in the fellow eye with BCVA 20/40 or better.
- Willing and able to comply with the schedule for power adjustment/lock-in treatments and the schedule for follow-up visits.
- Fully dilated pupil diameter of more than or equal to 7.0 mm.
Who cannot join
- Zonular laxity or dehiscence.
- Pseudoexfoliation.
- Age related macular degeneration involving the presence of geographic atrophy or soft drusen.
- Retinal degenerative disorder that is expected to cause future vision loss.
- Diabetes with any evidence of retinopathy.
- Evidence of glaucomatous optic neuropathy.
Show all 14Show fewer
- History of uveitis.
- Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris coloboma.
- Corneal pathology that is either progressive or sufficient to reduce BCVA to 20/25 or worse.
- Keratoconus or suspected of having keratoconus.
- Corneal dystrophy including basement membrane dystrophy.
- Previous corneal or intraocular surgery
- Systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, and phenothiazines.
- Complications during cataract surgery including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous loss, iris trauma, corneal complications or any intraoperative abnormality that may affect the postoperative pupillary dilation, or the centration or tilt of the intraocular lens.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Pepose Vision Institute
Chesterfield, Missouri, 63017
Price Vision Group
Indianapolis, Indiana, 46260
Discover Vision Centers
Leawood, Kansas, 66211
Altos Eye Physicians
Los Altos, California, 94024
Maloney Vision Institute
Los Angeles, California, 90024
About this study
Official title: A Prospective Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects Undergoing Cataract Extraction
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the LDD.
- Conditions
- Cataracts
- Being tested
- Lens implantation +1.00 D postop target, Lens implantation -1.00 D postop target, Lens implantation 0.00 D postop target
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens implantation +1.00 D postop targetDevice
Also called Light Delivery Device
Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Lens implantation -1.00 D postop targetDevice
Also called Light Delivery Device
Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Lens implantation 0.00 D postop targetDevice
Also called Light Delivery Device
Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
| Study group | Role | What they receive |
|---|---|---|
| Lens implantation +1.00 diopter (D) postop target | Experimental | Lens implant power calculated for postoperative MRSE target of +1.00 D Receives: Device: Lens implantation +1.00 D postop target |
| Lens implantation -1.00 D postop target | Experimental | Lens implant power calculated for postoperative MRSE target of -1.00 D Receives: Device: Lens implantation -1.00 D postop target |
| Lens implantation 0.00 D postop target | Experimental | Lens implant power calculated for postoperative MRSE target of 0.00 D Receives: Device: Lens implantation 0.00 D postop target |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.
Measured: 6 months post-operative
Secondary outcomes (1)
Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)
Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractsStudies 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
- Model description
- Phase 2 medical device study
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calhoun Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. Doyle Stulting, MD, PhD, Principal investigator, Emory Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845520
- Sponsor's protocol ID
- CSP 002-00
- Status last verified
- Jun 2018
- First submitted
- 13 Feb 2009
- Last updated
- 6 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects Undergoing Cataract Extraction
- ClinicalTrials.gov ID
- NCT00845520
- Acronym / sponsor ID
- CSP 002-00
- Conditions
- Cataracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Calhoun Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 6 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the LDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 2 medical device study
| Arm | Type | Receives |
|---|---|---|
| Lens implantation +1.00 diopter (D) postop target | Experimental | Device: Lens implantation +1.00 D postop targetLens implant power calculated for postoperative MRSE target of +1.00 D |
| Lens implantation -1.00 D postop target | Experimental | Device: Lens implantation -1.00 D postop targetLens implant power calculated for postoperative MRSE target of -1.00 D |
| Lens implantation 0.00 D postop target | Experimental | Device: Lens implantation 0.00 D postop targetLens implant power calculated for postoperative MRSE target of 0.00 D |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by keratometry.
- Adults between the ages of 40 and 80 inclusive.
- Cataract causing reduction in best spectacle-corrected visual acuity to a level of 20/32 or worse.
- Best corrected visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/25 or better after cataract removal and IOL implantation.
- Clear intraocular media other than cataract.
Key exclusion criteria (14 listed)
- Zonular laxity or dehiscence.
- Pseudoexfoliation.
- Age related macular degeneration involving the presence of geographic atrophy or soft drusen.
- Retinal degenerative disorder that is expected to cause future vision loss.
- Diabetes with any evidence of retinopathy.
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 |
|---|---|---|
| Lens implantation +1.00 D postop targetAlso: Light Delivery DeviceLens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction. | Device | Lens implantation +1.00 diopter (D) postop target |
| Lens implantation -1.00 D postop targetAlso: Light Delivery DeviceLens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction. | Device | Lens implantation -1.00 D postop target |
| Lens implantation 0.00 D postop targetAlso: Light Delivery DeviceLens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction. | Device | Lens implantation 0.00 D postop target |
Primary outcome
Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
Time frame: 6 months post-operative
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.
1 secondary outcome
Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)
Time frame: 6 months post operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
R. Doyle Stulting, MD, PhD principal investigator
Emory Eye Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens implantation +1.00 D postop target, Lens implantation -1.00 D postop target and Lens implantation 0.00 D postop target in people with Cataracts, run by Calhoun Vision, Inc. at 6 sites in 2 countries.
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 8 inclusion and 14 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Mexico. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target (time frame: 6 months post-operative). 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 6 Jul 2018.