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

Sponsor
Calhoun Vision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01496066
Collaborator
(none)
600
Enrollment
17
Locations
2
Arms
54
Duration (Months)
35.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
  • Device: Monofocal control IOL
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 3 medical device studyPhase 3 medical device study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

ArmIntervention/Treatment
Experimental: LAL

LAL implanted

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

Active Comparator: Monofocal control

Monofocal control IOL implanted

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

Outcome Measures

Primary Outcome Measures

  1. Percent Reduction in Manifest Cylinder [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.

  2. Percent Absolute Reduction in MRSE [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.

  3. Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop [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.

Secondary Outcome Measures

  1. Uncorrected Visual Acuity 20/20 or Better [6 months]

    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.

  2. Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) [6 months]

    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.

  3. Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) [6 months]

    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.

  4. Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively [6 months]

    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.

  5. Mean BSCVA [6 months]

    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).

Eligibility Criteria

Criteria

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

Exclusion Criteria:
  • 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

  • Corneal dystrophy, previous corneal or intraocular surgery

  • Complications during cataract surgery

  • Serious co-morbid conditions

  • Systemic medications that my increase UV sensitivity

  • Irregular astigmatism

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Vold VisionFayettevilleArkansasUnited States72704
2Jules Stein Eye InstituteLos AngelesCaliforniaUnited States90095
3Wolstan & Goldberg Eye AssociatesTorranceCaliforniaUnited States90505
4Newsom EyeSebringFloridaUnited States33870
5Arbor Centers for Eye CareOrland ParkIllinoisUnited States60467
6Eye Surgeons of IndianaIndianapolisIndianaUnited States46256
7Jones Eye ClinicSioux CityIowaUnited States51104
8Discover Vision & Laser CenterLeawoodKansasUnited States66211
9Minnesota Eye Consultants, PABloomingtonMinnesotaUnited States55431
10Ophthalmology Consultants, Ltd.Saint LouisMissouriUnited States63131
11EyeSight Ophthalmic Services, PASomersworthNew HampshireUnited States03878
12Carolina Vision CenterFayettevilleNorth CarolinaUnited States28304
13Cleveland Eye ClinicBrecksvilleOhioUnited States44141
14Vance Thompson VisionSioux FallsSouth DakotaUnited States57105
15Eye Consultants of TexasGrapevineTexasUnited States76051
16Focal Point VisionSan AntonioTexasUnited States78229
17Hoopes VisionDraperUtahUnited States84020

Sponsors and Collaborators

  • Calhoun Vision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Calhoun Vision, Inc.
ClinicalTrials.gov Identifier:
NCT01496066
Other Study ID Numbers:
  • CSP-002-03
First Posted:
Dec 21, 2011
Last Update Posted:
Jun 29, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleLAL ImplantMonofocal Control
Arm/Group DescriptionLAL implanted LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDDMonofocal control IOL implanted Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)
Period Title: Overall Study
STARTED403197
COMPLETED391188
NOT COMPLETED129

Baseline Characteristics

Arm/Group TitleLAL ImplantMonofocal ControlTotal
Arm/Group DescriptionLAL implanted LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDDMonofocal control IOL implanted Monofocal control IOL: Commercially available monofocal intraocular lens (IOL)Total of all reporting groups
Overall Participants403197600
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
65.6
(7.9)
66.6
(7.2)
66.2
(7.7)
Sex: Female, Male (Count of Participants)
Female
242
60%
102
51.8%
344
57.3%
Male
161
40%
95
48.2%
256
42.7%
Ethnicity (NIH/OMB) (Count of 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%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
0.2%
0
0%
1
0.2%
Asian
4
1%
0
0%
4
0.7%
Native Hawaiian or Other Pacific Islander
0
0%
2
1%
2
0.3%
Black or African American
15
3.7%
6
3%
21
3.5%
White
383
95%
188
95.4%
571
95.2%
More than one race
0
0%
1
0.5%
1
0.2%
Unknown or Not Reported
0
0%
0
0%
0
0%
Right Eye (Eyes) [Number]
Number [Eyes]
226
96
322
Left Eye (Eyes) [Number]
Number [Eyes]
177
101
278

Outcome Measures

1. Primary Outcome
TitlePercent Reduction in Manifest Cylinder
DescriptionPercent 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 Frame6 months

Outcome Measure Data

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 TitleLight Adjustable Lens ImplantedControl IOL Implanted
Arm/Group DescriptionRandomized to have the Light Adjustable Lens implantedRandomized to have the monofocal control IOL implanted
Measure Participants286126
Mean (95% Confidence Interval) [percent reduction in manifest cylinder]
74.6
19.9
2. Primary Outcome
TitlePercent Absolute Reduction in MRSE
DescriptionPercent 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 Frame6 months

Outcome Measure Data

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 TitleLight Adjustable LensMonofocal Control IOL
Arm/Group DescriptionEyes randomized to have Light Adjustable Lens implantedEyes randomized to have monofocal control IOL implanted
Measure Participants380166
Mean (95% Confidence Interval) [percentage of reduction in MRSE]
51.5
10.4
3. Primary Outcome
TitleRotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
DescriptionNumber (%) 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 Frame6 months

Outcome Measure Data

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 TitleLight Adjustable Lens
Arm/Group DescriptionEyes randomized to be implanted with the Light Adjustable Lens
Measure Participants358
Number (95% Confidence Interval) [percentage of eyes]
96.1
4. Secondary Outcome
TitleUncorrected Visual Acuity 20/20 or Better
DescriptionPercent 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 Frame6 months

Outcome Measure Data

Analysis Population Description
ITT
Arm/Group TitleLight Adjustable LensMonofocal Control IOL
Arm/Group DescriptionRandomized to have the Light Adjustable Lens implantedRandomized to have a Monofocal control IOL implanted
Measure Participants391193
Number [percentage of eyes]
70.1
36.3
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens Implanted, Control IOL Implanted
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<.0001
Comments
MethodChi-squared
Comments
5. Secondary Outcome
TitleMean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
DescriptionPercent 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 Frame6 months

Outcome Measure Data

Analysis Population Description
Participants with eyes in ITT with 0.75-1.25 D cylinder prior to light treatment
Arm/Group TitleLight Adjustable LensMonofocal Control IOL
Arm/Group DescriptionRandomized to have the Light Adjustable Lens implantedRandomized to have the monofocal control IOL implanted
Measure Participants20390
Mean (Standard Deviation) [percent reduction in cylinder]
73.4
(33.1)
18.6
(57.0)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens Implanted, Control IOL Implanted
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<.0001
Comments
Methodt-test, 2 sided
Comments
6. Secondary Outcome
TitleMean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
DescriptionPercent 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 Frame6 months

Outcome Measure Data

Analysis Population Description
Participants with eyes in ITT with >1.25 D of cylinder prior to light treatment
Arm/Group TitleLight Adjustable LensMonofocal Control IOL
Arm/Group DescriptionRandomized to have the Light Adjustable Lens implantedRandomized to have the monofocal control IOL implanted
Measure Participants8336
Mean (Standard Deviation) [percent reduction in cylinder]
77.5
(20.7)
23.1
(32.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens Implanted, Control IOL Implanted
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value<.0001
Comments
Methodt-test, 2 sided
Comments
7. Secondary Outcome
TitlePercent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
DescriptionFor 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 Frame6 months

Outcome Measure Data

Analysis Population Description
Participants with eyes in ITT with <0.75 D of cylinder prior to light treatment
Arm/Group TitleLight Adjustable LensMonofocal Control IOL
Arm/Group DescriptionRandomized to have the Light Adjustable Lens implantedRandomized to have the monofocal control IOL implanted
Measure Participants10053
Mean (Standard Deviation) [percent absolute reduction in MRSE]
55.2
(76.3)
27.2
(75.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens Implanted, Control IOL Implanted
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value.0318
Comments
Methodt-test, 2 sided
Comments
8. Secondary Outcome
TitleMean BSCVA
DescriptionMean 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 Frame6 months

Outcome Measure Data

Analysis Population Description
ITT population best case cohort with no macular problems
Arm/Group TitleLight Adjustable LensMonofocal Control IOL
Arm/Group DescriptionRandomized to have the Light Adjustable Lens implantedRandomized to have the Monofocal control IOL implanted
Measure Participants390191
Mean (Standard Deviation) [LogMAR]
-0.066
(0.083)
-0.029
(0.090)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Light Adjustable Lens Implanted, Control IOL Implanted
Comments
Type of Statistical Test Equivalence
Comments a two-group t-test of equivalence in means was used
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value-0.04
Confidence Interval (2-Sided) 99%
-0.06 to -0.02
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame12 months
Adverse Event Reporting Description
Arm/Group TitleLight Adjustable LensMonofocal Control IOL
Arm/Group DescriptionRandomized to have the Light Adjustable Lens implantedRandomized to have the Monofocal control IOL implanted
All Cause Mortality
Light Adjustable LensMonofocal Control IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/403 (0.2%) 4/197 (2%)
Serious Adverse Events
Light Adjustable LensMonofocal Control IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total42/403 (10.4%) 10/197 (5.1%)
Blood and lymphatic system disorders
Blood clots due to lymphoma0/403 (0%) 01/197 (0.5%) 1
Cardiac disorders
Chest pain with pacemaker1/403 (0.2%) 10/197 (0%) 0
Heart palpitations1/403 (0.2%) 10/197 (0%) 0
Heart surgery1/403 (0.2%) 10/197 (0%) 0
Triple bypass surgery0/403 (0%) 01/197 (0.5%) 1
Eye disorders
Herpetic Keratouveitis1/403 (0.2%) 10/197 (0%) 0
Persistent Induced Tritan Color Anomaly2/403 (0.5%) 20/197 (0%) 0
Cystoid Macular Edema3/403 (0.7%) 33/197 (1.5%) 3
Endophthalmitis1/403 (0.2%) 10/197 (0%) 0
Horseshoe retinal tear with vitreous hemorrhage1/403 (0.2%) 11/197 (0.5%) 1
Hypopyon1/403 (0.2%) 10/197 (0%) 0
Surgical complication1/403 (0.2%) 10/197 (0%) 0
Secondary surgical intervention7/403 (1.7%) 71/197 (0.5%) 1
Phytotoxic retinal damage causing temporary loss of BSCVA1/403 (0.2%) 10/197 (0%) 0
Persistent induced erythropsia1/403 (0.2%) 10/197 (0%) 0
Persistent unanticipated increase refractive error5/403 (1.2%) 50/197 (0%) 0
Intraoperative capsular tear1/403 (0.2%) 10/197 (0%) 0
Gastrointestinal disorders
Hospitalization for colitis1/403 (0.2%) 10/197 (0%) 0
General disorders
Broken wrist1/403 (0.2%) 10/197 (0%) 0
Hospitalization due to syncope1/403 (0.2%) 10/197 (0%) 0
Hospitalization due to low blood pressure and syncope1/403 (0.2%) 10/197 (0%) 0
Hospitalization due to dizziness1/403 (0.2%) 10/197 (0%) 0
Infections and infestations
Hospitalization due to cellulitis1/403 (0.2%) 10/197 (0%) 0
Hospitalization due to infection after knee surgery1/403 (0.2%) 10/197 (0%) 0
Injury, poisoning and procedural complications
Hospitalization due to concussion with subdural hematoma1/403 (0.2%) 10/197 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer1/403 (0.2%) 10/197 (0%) 0
Liver cancer1/403 (0.2%) 10/197 (0%) 0
Malignant neuroendocrine tumors0/403 (0%) 01/197 (0.5%) 1
Nervous system disorders
Anxiety1/403 (0.2%) 10/197 (0%) 0
Renal and urinary disorders
Kidney disease1/403 (0.2%) 10/197 (0%) 0
Respiratory, thoracic and mediastinal disorders
COPD1/403 (0.2%) 10/197 (0%) 0
Hospitalization due to emphysema/COPD1/403 (0.2%) 10/197 (0%) 0
Vascular disorders
Broken blood vessel in brain0/403 (0%) 01/197 (0.5%) 1
Stroke2/403 (0.5%) 20/197 (0%) 0
Transient ischemic attack0/403 (0%) 01/197 (0.5%) 1
Other (Not Including Serious) Adverse Events
Light Adjustable LensMonofocal Control IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total292/403 (72.5%) 125/197 (63.5%)
Eye disorders
Anterior chamber cells43/403 (10.7%) 4321/197 (10.7%) 21
Anterior chamber flare19/403 (4.7%) 1911/197 (5.6%) 11
Blurred vision31/403 (7.7%) 3119/197 (9.6%) 19
Corneal edema central25/403 (6.2%) 2513/197 (6.6%) 13
corneal edema wound43/403 (10.7%) 4314/197 (7.1%) 14
Posterior capsular opacity51/403 (12.7%) 5126/197 (13.2%) 26
Raised IOP not requiring treatment32/403 (7.9%) 322/197 (1%) 2
Raised IOP requiring treatment26/403 (6.5%) 2614/197 (7.1%) 14
Superficial punctate keratitis22/403 (5.5%) 225/197 (2.5%) 5

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.

Results Point of Contact

Name/TitleMaureen O'Connell Vice President, Regulator and Clinical Affairs
OrganizationRxSight, Inc.
Phone978-207-12415
Emailmoconnell@rxsight.com
Responsible Party:
Calhoun Vision, Inc.
ClinicalTrials.gov Identifier:
NCT01496066
Other Study ID Numbers:
  • CSP-002-03
First Posted:
Dec 21, 2011
Last Update Posted:
Jun 29, 2018
Last Verified:
May 1, 2018