CataractNCT01496066
Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
A study testing LAL (Light Adjustable Lens) and Light Deliver Device (LDD) in people with Cataract, run by Calhoun Vision, Inc. at 17 sites in United States.
Trial summary
The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2011to Jun 2016
- 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
- Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted
- Pre-operative regular corneal astigmatism of >= 0.75 diopters and <= 2.0 diopters
- Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare
- Projected best spectacle corrected visual acuity of 20/20 or better
- Clear intraocular media other than cataract
- Potentially good vision in fellow eye
- Fully dilated pupil of >= 7.0 mm
Who cannot join
- Zonular laxity or dehiscence
- Pseudoexfoliation
- Age related macular degeneration
- Retinal degenerative disorder
- Diabetes with any evidence of retinopathy
- Glaucomatous optic neuropathy, uveitis, significant anterior segment pathology, keratoconus
Show all 11Show fewer
- Corneal dystrophy, previous corneal or intraocular surgery
- Complications during cataract surgery
- Serious co-morbid conditions
- Systemic medications that my increase UV sensitivity
- Irregular astigmatism
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Hoopes Vision
Draper, Utah, 84020
Vold Vision
Fayetteville, Arkansas, 72704
Carolina Vision Center
Fayetteville, North Carolina, 28304
Eye Consultants of Texas
Grapevine, Texas, 76051
Eye Surgeons of Indiana
Indianapolis, Indiana, 46256
Discover Vision & Laser Center
Leawood, Kansas, 66211
Jules Stein Eye Institute
Los Angeles, California, 90095
Arbor Centers for Eye Care
Orland Park, Illinois, 60467
Focal Point Vision
San Antonio, Texas, 78229
Newsom Eye
Sebring, Florida, 33870
Jones Eye Clinic
Sioux City, Iowa, 51104
Vance Thompson Vision
Sioux Falls, South Dakota, 57105
EyeSight Ophthalmic Services, PA
Somersworth, New Hampshire, 03878
Ophthalmology Consultants, Ltd.
St Louis, Missouri, 63131
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
Official title: A Prospective Randomized Controlled Multi-Center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.
- Conditions
- Cataract
- Being tested
- LAL (Light Adjustable Lens) and Light Deliver Device (LDD), Monofocal control IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAL (Light Adjustable Lens) and Light Deliver Device (LDD)Device
LAL implanted and adjusted with LDD
Monofocal control IOLDevice
Commercially available monofocal intraocular lens (IOL)
| Study group | Role | What they receive |
|---|---|---|
| LAL | Experimental | LAL implanted Receives: Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD) |
| Monofocal control | Active comparator | Monofocal control IOL implanted Receives: Device: Monofocal control IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Reduction in Manifest Cylinder
Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
Measured: 6 months
Percent Absolute Reduction in MRSE
Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
Measured: 6 months
Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.
Measured: 6 months
Secondary outcomes (5)
Uncorrected Visual Acuity 20/20 or Better
Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively.
Measured: 6 months
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately.
Measured: 6 months
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group.
Measured: 6 months
Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
For eyes with <0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group.
Measured: 6 months
Mean BSCVA
Mean BSCVA for the "best case" cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2016
- Study completionJun 2016
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 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
- Model description
- Phase 3 medical device study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calhoun Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496066
- Sponsor's protocol ID
- CSP-002-03
- Status last verified
- May 2018
- First submitted
- 15 Dec 2011
- Last updated
- 29 Jun 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 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Multi-Center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
- ClinicalTrials.gov ID
- NCT01496066
- Acronym / sponsor ID
- CSP-002-03
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Calhoun Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Posted 5 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 3 medical device study
| Arm | Type | Receives |
|---|---|---|
| LAL | Experimental | Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)LAL implanted |
| Monofocal control | Active comparator | Device: Monofocal control IOLMonofocal control IOL implanted |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted
- Pre-operative regular corneal astigmatism of >= 0.75 diopters and <= 2.0 diopters
- Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare
- Projected best spectacle corrected visual acuity of 20/20 or better
- Clear intraocular media other than cataract
Key exclusion criteria (11 listed)
- Zonular laxity or dehiscence
- Pseudoexfoliation
- Age related macular degeneration
- Retinal degenerative disorder
- 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 |
|---|---|---|
| LAL (Light Adjustable Lens) and Light Deliver Device (LDD)LAL implanted and adjusted with LDD | Device | LAL |
| Monofocal control IOLCommercially available monofocal intraocular lens (IOL) | Device | Monofocal control |
Primary outcome
Percent Reduction in Manifest Cylinder
Time frame: 6 months
Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
Percent Absolute Reduction in MRSE
Time frame: 6 months
Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
Time frame: 6 months
Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.
5 secondary outcomes
Uncorrected Visual Acuity 20/20 or Better
Time frame: 6 months
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
Time frame: 6 months
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
Time frame: 6 months
Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
Time frame: 6 months
Mean BSCVA
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAL (Light Adjustable Lens) and Light Deliver Device (LDD) in people with Cataract, run by Calhoun Vision, Inc. at 17 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 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Yes. Results are posted in the registry (first posted 5 Mar 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?
Percent Reduction in Manifest Cylinder (time frame: 6 months). The study lists 3 primary outcomes in all. 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 29 Jun 2018.