Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)

• Sponsor: Calhoun Vision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00845520
• Collaborator: (none)
• Enrollment: 74
• Locations: 6
• Arms: 3
• Duration (Months): 49.9
• Patients Per Site: 12.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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 of the LAL power and lock-in treatments with the LDD.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: Lens implantation +1.00 D postop target; Device: Lens implantation -1.00 D postop target; Device: Lens implantation 0.00 D postop target	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase 2 medical device studyPhase 2 medical device study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lens implantation +1.00 diopter (D) postop target Lens implant power calculated for postoperative MRSE target of +1.00 D	Device: Lens implantation +1.00 D postop target; Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.; Other Names: Light Delivery Device
Experimental: Lens implantation -1.00 D postop target Lens implant power calculated for postoperative MRSE target of -1.00 D	Device: Lens implantation -1.00 D postop target; Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.; Other Names: Light Delivery Device
Experimental: Lens implantation 0.00 D postop target Lens implant power calculated for postoperative MRSE target of 0.00 D	Device: Lens implantation 0.00 D postop target; Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.; Other Names: Light Delivery Device

Outcome Measures

Primary Outcome Measures

1. Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target [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.

Secondary Outcome Measures

1. Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA) [6 months post operative]

   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.

Other Outcome Measures

1. Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better [12 months]

   Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altos Eye Physicians	Los Altos	California	United States	94024
2	Maloney Vision Institute	Los Angeles	California	United States	90024
3	Price Vision Group	Indianapolis	Indiana	United States	46260
4	Discover Vision Centers	Leawood	Kansas	United States	66211
5	Pepose Vision Institute	Chesterfield	Missouri	United States	63017
6	CODET Vision Institute	Tijuana	Zona Rio	Mexico	22320

Sponsors and Collaborators

• Calhoun Vision, Inc.

Investigators

• Principal Investigator: R. Doyle Stulting, MD, PhD, Emory Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Calhoun Vision, Inc.
• ClinicalTrials.gov Identifier: NCT00845520
• Other Study ID Numbers: CSP 002-00
• First Posted: Feb 18, 2009
• Last Update Posted: Jul 6, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	Lens Implant Power +1.00 D Target	Lens Implant Power -1.00 D Target	Lens Implant Power 0.00 D Target
Arm/Group Description	Lens implant power +1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative +1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.	Lens implant power -1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative -1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.	Lens implant power 0.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative 0.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
Period Title: Overall Study
STARTED	25	25	24
COMPLETED	23	23	23
NOT COMPLETED	2	2	1

Baseline Characteristics

Arm/Group Title	Lens Implant Power +1.00 D Target	Lens Implant Power 0.00 D Target	Lens Implant Power -1.00 D Target	Total
Arm/Group Description	The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 diopter	The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 diopter	The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 11.00 diopter	Total of all reporting groups
Overall Participants	25	24	25	74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.3 (9.3)	65.6 (7.3)	65.9 (9.2)	66.1 (8.6)
Sex: Female, Male (Count of Participants)
Female	15 60%	17 70.8%	12 48%	44 59.5%
Male	10 40%	7 29.2%	13 52%	30 40.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	1 4.2%	0 0%	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 4%	0 0%	0 0%	1 1.4%
White	21 84%	15 62.5%	19 76%	55 74.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	3 12%	8 33.3%	6 24%	17 23%

Outcome Measures

1. Primary Outcome

Title	Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
Description	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.
Time Frame	6 months post-operative

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Lens Implant Power -1.00 D Target	Lens Implant Power +1.00 D Target	Lens Implant Power 0.00 D Target
Arm/Group Description	Eyes randomized to a target lens implant power of -1.00 D	Eyes randomized to a target lens implant power of +1.00 D	Eyes randomized to a target lens implant power of 0.00 D
Measure Participants	23	25	24
Number [percentage of eyes]	78.3	80.0	79.2

2. Secondary Outcome

Title	Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)
Description	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.
Time Frame	6 months post operative

Outcome Measure Data

Analysis Population Description

Participants with eyes with UCVA of 20/50 or worse UCVA prior to light treatment

Arm/Group Title	Lens Implant Power -1.00 D Target	Lens Implant Power of +1.00 D	Lens Implant Power of 0.0 D Target
Arm/Group Description	Eyes randomized to a target of -1.00 D	Eyes randomized to a target of +1.00 D	Eyes randomized to a target of 0.0 D
Measure Participants	10	1	1
Number [percentage of eyes]	77.8	100	0

3. Other Pre-specified Outcome

Title	Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better
Description	Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available eyes at 12 months. The overall number of participants for this outcome measures differs the previously stated overall number of 74 because two subjects were deceased at their 12 month post-operative follow up visit.

Arm/Group Title	Lens Implant Power With -1.00 D Target	Lens Implant Power With 0.00 D Target	Lens Implant Power With +1.00 D Target
Arm/Group Description	Eyes randomized to a postoperative target MRSE of -1.00 D	Eyes randomized to a postoperative target MRSE of 0.00 D	Eyes randomized to a postoperative target MRSE of +1.00 D
Measure Participants	23	24	25
Number [percentage of eyes]	100	100	100

Adverse Events

Time Frame	36 months
Arm/Group Title	Lens Implant Power of +1.00 D Target		Lens Implant Power of -1.00 D Target		Lens Implant Power of 0.00 D
Arm/Group Description	Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 D		Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of -1.00 D		Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 D
All Cause Mortality
	Lens Implant Power of +1.00 D Target		Lens Implant Power of -1.00 D Target		Lens Implant Power of 0.00 D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		2/25 (8%)		1/24 (4.2%)
Serious Adverse Events
	Lens Implant Power of +1.00 D Target		Lens Implant Power of -1.00 D Target		Lens Implant Power of 0.00 D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/25 (12%)		2/25 (8%)		1/24 (4.2%)
Cardiac disorders
heart attack with pacemaker implanted	0/25 (0%)	0	0/25 (0%)	0	1/24 (4.2%)	1
Eye disorders
Secondary Surgical Intervention	1/25 (4%)	1	1/25 (4%)	1	1/24 (4.2%)	1
Optic neuritis	1/25 (4%)	1	0/25 (0%)	0	0/24 (0%)	0
epiretinal membrane and macular hole	0/25 (0%)	0	0/25 (0%)	0	1/24 (4.2%)	1
wet age related macular degeneration	0/25 (0%)	0	1/25 (4%)	1	0/24 (0%)	0
macular edema secondary to epiretinal membrate	1/25 (4%)	1	0/25 (0%)	0	0/24 (0%)	0
Nervous system disorders
Stroke	0/25 (0%)	0	1/25 (4%)	1	0/24 (0%)	0
Other (Not Including Serious) Adverse Events
	Lens Implant Power of +1.00 D Target		Lens Implant Power of -1.00 D Target		Lens Implant Power of 0.00 D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/25 (72%)		15/25 (60%)		14/24 (58.3%)
Eye disorders
Posterior Capsular Opacity	17/25 (68%)	33	15/25 (60%)	37	13/24 (54.2%)	30
Blepharitis	1/25 (4%)	3	1/25 (4%)	1	2/24 (8.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.