Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01496066
Recruitment Status : Completed
First Posted : December 21, 2011
Results First Posted : March 5, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Calhoun Vision, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
Device: Monofocal control IOL
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LAL Implant Monofocal Control
Hide Arm/Group Description

LAL implanted

LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD

Monofocal control IOL implanted

Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)

Period Title: Overall Study
Started 403 197
Completed 391 188
Not Completed 12 9
Reason Not Completed
Lost to Follow-up             8             5
Explant             3             0
Death             1             4
Arm/Group Title LAL Implant Monofocal Control Total
Hide Arm/Group Description

LAL implanted

LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD

Monofocal control IOL implanted

Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)

Total of all reporting groups
Overall Number of Baseline Participants 403 197 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 403 participants 197 participants 600 participants
65.6  (7.9) 66.6  (7.2) 66.2  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 197 participants 600 participants
Female
242
  60.0%
102
  51.8%
344
  57.3%
Male
161
  40.0%
95
  48.2%
256
  42.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 197 participants 600 participants
Hispanic or Latino
18
   4.5%
7
   3.6%
25
   4.2%
Not Hispanic or Latino
385
  95.5%
190
  96.4%
575
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 197 participants 600 participants
American Indian or Alaska Native
1
   0.2%
0
   0.0%
1
   0.2%
Asian
4
   1.0%
0
   0.0%
4
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   1.0%
2
   0.3%
Black or African American
15
   3.7%
6
   3.0%
21
   3.5%
White
383
  95.0%
188
  95.4%
571
  95.2%
More than one race
0
   0.0%
1
   0.5%
1
   0.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Right Eye  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 403 participants 197 participants 600 participants
226 96 322
Left Eye  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 403 participants 197 participants 600 participants
177 101 278
1.Primary Outcome
Title Percent Reduction in Manifest Cylinder
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Only eyes that had cylinder in the range of treatment (>=0.75 D) were included in the analysis. Therefore the number of participants analyzed for this outcome measure will not match the overall number of participants in the study.
Arm/Group Title Light Adjustable Lens Implanted Control IOL Implanted
Hide Arm/Group Description:
Randomized to have the Light Adjustable Lens implanted
Randomized to have the monofocal control IOL implanted
Overall Number of Participants Analyzed 286 126
Mean (95% Confidence Interval)
Unit of Measure: percent reduction in manifest cylinder
74.6
(71.1 to 78.1)
19.9
(10.9 to 28.9)
2.Primary Outcome
Title Percent Absolute Reduction in MRSE
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Any eyes that had an MRSE of zero at Pre-Adjustment were excluded since it is not possible to divide by zero. Therefore the number participants analyzed for this outcome will differ from the number of overall participants in the study.
Arm/Group Title Light Adjustable Lens Monofocal Control IOL
Hide Arm/Group Description:
Eyes randomized to have Light Adjustable Lens implanted
Eyes randomized to have monofocal control IOL implanted
Overall Number of Participants Analyzed 380 166
Mean (95% Confidence Interval)
Unit of Measure: percentage of reduction in MRSE
51.5
(43.8 to 59.1)
10.4
(-3.8 to 24.7)
3.Primary Outcome
Title Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT: The overall number of participants analyzed differs from the other outcome measures because some photographs were unusable due to inadequate lighting, user error, or equipment failure.
Arm/Group Title Light Adjustable Lens
Hide Arm/Group Description:
Eyes randomized to be implanted with the Light Adjustable Lens
Overall Number of Participants Analyzed 358
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of eyes
96.1
(93.5 to 97.8)
4.Secondary Outcome
Title Uncorrected Visual Acuity 20/20 or Better
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Light Adjustable Lens Monofocal Control IOL
Hide Arm/Group Description:
Randomized to have the Light Adjustable Lens implanted
Randomized to have a Monofocal control IOL implanted
Overall Number of Participants Analyzed 391 193
Measure Type: Number
Unit of Measure: percentage of eyes
70.1 36.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens, Monofocal Control IOL
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with eyes in ITT with 0.75-1.25 D cylinder prior to light treatment
Arm/Group Title Light Adjustable Lens Monofocal Control IOL
Hide Arm/Group Description:
Randomized to have the Light Adjustable Lens implanted
Randomized to have the monofocal control IOL implanted
Overall Number of Participants Analyzed 203 90
Mean (Standard Deviation)
Unit of Measure: percent reduction in cylinder
73.4  (33.1) 18.6  (57.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens, Monofocal Control IOL
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with eyes in ITT with >1.25 D of cylinder prior to light treatment
Arm/Group Title Light Adjustable Lens Monofocal Control IOL
Hide Arm/Group Description:
Randomized to have the Light Adjustable Lens implanted
Randomized to have the monofocal control IOL implanted
Overall Number of Participants Analyzed 83 36
Mean (Standard Deviation)
Unit of Measure: percent reduction in cylinder
77.5  (20.7) 23.1  (32.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens, Monofocal Control IOL
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with eyes in ITT with <0.75 D of cylinder prior to light treatment
Arm/Group Title Light Adjustable Lens Monofocal Control IOL
Hide Arm/Group Description:
Randomized to have the Light Adjustable Lens implanted
Randomized to have the monofocal control IOL implanted
Overall Number of Participants Analyzed 100 53
Mean (Standard Deviation)
Unit of Measure: percent absolute reduction in MRSE
55.2  (76.3) 27.2  (75.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens, Monofocal Control IOL
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0318
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Mean BSCVA
Hide Description 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).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population best case cohort with no macular problems
Arm/Group Title Light Adjustable Lens Monofocal Control IOL
Hide Arm/Group Description:
Randomized to have the Light Adjustable Lens implanted
Randomized to have the Monofocal control IOL implanted
Overall Number of Participants Analyzed 390 191
Mean (Standard Deviation)
Unit of Measure: LogMAR
-0.066  (0.083) -0.029  (0.090)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens, Monofocal Control IOL
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments a two-group t-test of equivalence in means was used
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 99%
-0.06 to -0.02
Estimation Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Light Adjustable Lens Monofocal Control IOL
Hide Arm/Group Description Randomized to have the Light Adjustable Lens implanted Randomized to have the Monofocal control IOL implanted
All-Cause Mortality
Light Adjustable Lens Monofocal Control IOL
Affected / at Risk (%) Affected / at Risk (%)
Total   1/403 (0.25%)      4/197 (2.03%)    
Show Serious Adverse Events Hide Serious Adverse Events
Light Adjustable Lens Monofocal Control IOL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/403 (10.42%)      10/197 (5.08%)    
Blood and lymphatic system disorders     
Blood clots due to lymphoma   0/403 (0.00%)  0 1/197 (0.51%)  1
Cardiac disorders     
Chest pain with pacemaker   1/403 (0.25%)  1 0/197 (0.00%)  0
Heart palpitations   1/403 (0.25%)  1 0/197 (0.00%)  0
Heart surgery   1/403 (0.25%)  1 0/197 (0.00%)  0
Triple bypass surgery   0/403 (0.00%)  0 1/197 (0.51%)  1
Eye disorders     
Herpetic Keratouveitis   1/403 (0.25%)  1 0/197 (0.00%)  0
Persistent Induced Tritan Color Anomaly   2/403 (0.50%)  2 0/197 (0.00%)  0
Cystoid Macular Edema   3/403 (0.74%)  3 3/197 (1.52%)  3
Endophthalmitis   1/403 (0.25%)  1 0/197 (0.00%)  0
Horseshoe retinal tear with vitreous hemorrhage   1/403 (0.25%)  1 1/197 (0.51%)  1
Hypopyon   1/403 (0.25%)  1 0/197 (0.00%)  0
Surgical complication  [1]  1/403 (0.25%)  1 0/197 (0.00%)  0
Secondary surgical intervention   7/403 (1.74%)  7 1/197 (0.51%)  1
Phytotoxic retinal damage causing temporary loss of BSCVA   1/403 (0.25%)  1 0/197 (0.00%)  0
Persistent induced erythropsia   1/403 (0.25%)  1 0/197 (0.00%)  0
Persistent unanticipated increase refractive error   5/403 (1.24%)  5 0/197 (0.00%)  0
Intraoperative capsular tear   1/403 (0.25%)  1 0/197 (0.00%)  0
Gastrointestinal disorders     
Hospitalization for colitis   1/403 (0.25%)  1 0/197 (0.00%)  0
General disorders     
Broken wrist   1/403 (0.25%)  1 0/197 (0.00%)  0
Hospitalization due to syncope   1/403 (0.25%)  1 0/197 (0.00%)  0
Hospitalization due to low blood pressure and syncope   1/403 (0.25%)  1 0/197 (0.00%)  0
Hospitalization due to dizziness   1/403 (0.25%)  1 0/197 (0.00%)  0
Infections and infestations     
Hospitalization due to cellulitis   1/403 (0.25%)  1 0/197 (0.00%)  0
Hospitalization due to infection after knee surgery   1/403 (0.25%)  1 0/197 (0.00%)  0
Injury, poisoning and procedural complications     
Hospitalization due to concussion with subdural hematoma   1/403 (0.25%)  1 0/197 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer   1/403 (0.25%)  1 0/197 (0.00%)  0
Liver cancer   1/403 (0.25%)  1 0/197 (0.00%)  0
Malignant neuroendocrine tumors   0/403 (0.00%)  0 1/197 (0.51%)  1
Nervous system disorders     
Anxiety   1/403 (0.25%)  1 0/197 (0.00%)  0
Renal and urinary disorders     
Kidney disease   1/403 (0.25%)  1 0/197 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
COPD   1/403 (0.25%)  1 0/197 (0.00%)  0
Hospitalization due to emphysema/COPD   1/403 (0.25%)  1 0/197 (0.00%)  0
Vascular disorders     
Broken blood vessel in brain   0/403 (0.00%)  0 1/197 (0.51%)  1
Stroke   2/403 (0.50%)  2 0/197 (0.00%)  0
Transient ischemic attack   0/403 (0.00%)  0 1/197 (0.51%)  1
Indicates events were collected by systematic assessment
[1]
Surgical complication including anterior segment bleeding, vitreous loss, and posterior capsule and zonular rupture
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Light Adjustable Lens Monofocal Control IOL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   292/403 (72.46%)      125/197 (63.45%)    
Eye disorders     
Anterior chamber cells   43/403 (10.67%)  43 21/197 (10.66%)  21
Anterior chamber flare   19/403 (4.71%)  19 11/197 (5.58%)  11
Blurred vision   31/403 (7.69%)  31 19/197 (9.64%)  19
Corneal edema central   25/403 (6.20%)  25 13/197 (6.60%)  13
corneal edema wound   43/403 (10.67%)  43 14/197 (7.11%)  14
Posterior capsular opacity   51/403 (12.66%)  51 26/197 (13.20%)  26
Raised IOP not requiring treatment   32/403 (7.94%)  32 2/197 (1.02%)  2
Raised IOP requiring treatment   26/403 (6.45%)  26 14/197 (7.11%)  14
Superficial punctate keratitis   22/403 (5.46%)  22 5/197 (2.54%)  5
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Maureen O'Connell Vice President, Regulator and Clinical Affairs
Organization: RxSight, Inc.
Phone: 978-207-12415
Responsible Party: Calhoun Vision, Inc.
ClinicalTrials.gov Identifier: NCT01496066     History of Changes
Other Study ID Numbers: CSP-002-03
First Submitted: December 15, 2011
First Posted: December 21, 2011
Results First Submitted: December 29, 2017
Results First Posted: March 5, 2018
Last Update Posted: June 29, 2018