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)
• Enrollment: 600
• Locations: 17
• Arms: 2
• Duration (Months): 54
• Patients Per Site: 35.3
• Patients Per Site Per Month: 0.7

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 Disease	Intervention/Treatment	Phase
Cataract	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Vold Vision	Fayetteville	Arkansas	United States	72704
2	Jules Stein Eye Institute	Los Angeles	California	United States	90095
3	Wolstan & Goldberg Eye Associates	Torrance	California	United States	90505
4	Newsom Eye	Sebring	Florida	United States	33870
5	Arbor Centers for Eye Care	Orland Park	Illinois	United States	60467
6	Eye Surgeons of Indiana	Indianapolis	Indiana	United States	46256
7	Jones Eye Clinic	Sioux City	Iowa	United States	51104
8	Discover Vision & Laser Center	Leawood	Kansas	United States	66211
9	Minnesota Eye Consultants, PA	Bloomington	Minnesota	United States	55431
10	Ophthalmology Consultants, Ltd.	Saint Louis	Missouri	United States	63131
11	EyeSight Ophthalmic Services, PA	Somersworth	New Hampshire	United States	03878
12	Carolina Vision Center	Fayetteville	North Carolina	United States	28304
13	Cleveland Eye Clinic	Brecksville	Ohio	United States	44141
14	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57105
15	Eye Consultants of Texas	Grapevine	Texas	United States	76051
16	Focal Point Vision	San Antonio	Texas	United States	78229
17	Hoopes Vision	Draper	Utah	United States	84020

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: Cataract; Astigmatism

Study Results

Participant Flow

Arm/Group Title	LAL Implant	Monofocal Control
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

Baseline Characteristics

Arm/Group Title	LAL Implant	Monofocal Control	Total
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 Participants	403	197	600
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

Title	Percent Reduction in Manifest Cylinder
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

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 Title	Light Adjustable Lens Implanted	Control IOL Implanted
Arm/Group Description	Randomized to have the Light Adjustable Lens implanted	Randomized to have the monofocal control IOL implanted
Measure Participants	286	126
Mean (95% Confidence Interval) [percent reduction in manifest cylinder]	74.6	19.9

2. Primary Outcome

Title	Percent Absolute Reduction in MRSE
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

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 Title	Light Adjustable Lens	Monofocal Control IOL
Arm/Group Description	Eyes randomized to have Light Adjustable Lens implanted	Eyes randomized to have monofocal control IOL implanted
Measure Participants	380	166
Mean (95% Confidence Interval) [percentage of reduction in MRSE]	51.5	10.4

3. Primary Outcome

Title	Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
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

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 Title	Light Adjustable Lens
Arm/Group Description	Eyes randomized to be implanted with the Light Adjustable Lens
Measure Participants	358
Number (95% Confidence Interval) [percentage of eyes]	96.1

4. Secondary Outcome

Title	Uncorrected Visual Acuity 20/20 or Better
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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Light Adjustable Lens	Monofocal Control IOL
Arm/Group Description	Randomized to have the Light Adjustable Lens implanted	Randomized to have a Monofocal control IOL implanted
Measure Participants	391	193
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 Hypothesis	p-Value	<.0001
	Comments
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
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

Outcome Measure Data

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
Arm/Group Description	Randomized to have the Light Adjustable Lens implanted	Randomized to have the monofocal control IOL implanted
Measure Participants	203	90
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 Hypothesis	p-Value	<.0001
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
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

Outcome Measure Data

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
Arm/Group Description	Randomized to have the Light Adjustable Lens implanted	Randomized to have the monofocal control IOL implanted
Measure Participants	83	36
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 Hypothesis	p-Value	<.0001
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
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

Outcome Measure Data

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
Arm/Group Description	Randomized to have the Light Adjustable Lens implanted	Randomized to have the monofocal control IOL implanted
Measure Participants	100	53
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 Hypothesis	p-Value	.0318
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Mean BSCVA
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

Outcome Measure Data

Analysis Population Description

ITT population best case cohort with no macular problems

Arm/Group Title	Light Adjustable Lens	Monofocal Control IOL
Arm/Group Description	Randomized to have the Light Adjustable Lens implanted	Randomized to have the Monofocal control IOL implanted
Measure Participants	390	191
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 Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean 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 Frame	12 months
Arm/Group Title	Light Adjustable Lens		Monofocal Control IOL
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	1/403 (0.2%)		4/197 (2%)
Serious Adverse Events
	Light Adjustable Lens		Monofocal Control IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	42/403 (10.4%)		10/197 (5.1%)
Blood and lymphatic system disorders
Blood clots due to lymphoma	0/403 (0%)	0	1/197 (0.5%)	1
Cardiac disorders
Chest pain with pacemaker	1/403 (0.2%)	1	0/197 (0%)	0
Heart palpitations	1/403 (0.2%)	1	0/197 (0%)	0
Heart surgery	1/403 (0.2%)	1	0/197 (0%)	0
Triple bypass surgery	0/403 (0%)	0	1/197 (0.5%)	1
Eye disorders
Herpetic Keratouveitis	1/403 (0.2%)	1	0/197 (0%)	0
Persistent Induced Tritan Color Anomaly	2/403 (0.5%)	2	0/197 (0%)	0
Cystoid Macular Edema	3/403 (0.7%)	3	3/197 (1.5%)	3
Endophthalmitis	1/403 (0.2%)	1	0/197 (0%)	0
Horseshoe retinal tear with vitreous hemorrhage	1/403 (0.2%)	1	1/197 (0.5%)	1
Hypopyon	1/403 (0.2%)	1	0/197 (0%)	0
Surgical complication	1/403 (0.2%)	1	0/197 (0%)	0
Secondary surgical intervention	7/403 (1.7%)	7	1/197 (0.5%)	1
Phytotoxic retinal damage causing temporary loss of BSCVA	1/403 (0.2%)	1	0/197 (0%)	0
Persistent induced erythropsia	1/403 (0.2%)	1	0/197 (0%)	0
Persistent unanticipated increase refractive error	5/403 (1.2%)	5	0/197 (0%)	0
Intraoperative capsular tear	1/403 (0.2%)	1	0/197 (0%)	0
Gastrointestinal disorders
Hospitalization for colitis	1/403 (0.2%)	1	0/197 (0%)	0
General disorders
Broken wrist	1/403 (0.2%)	1	0/197 (0%)	0
Hospitalization due to syncope	1/403 (0.2%)	1	0/197 (0%)	0
Hospitalization due to low blood pressure and syncope	1/403 (0.2%)	1	0/197 (0%)	0
Hospitalization due to dizziness	1/403 (0.2%)	1	0/197 (0%)	0
Infections and infestations
Hospitalization due to cellulitis	1/403 (0.2%)	1	0/197 (0%)	0
Hospitalization due to infection after knee surgery	1/403 (0.2%)	1	0/197 (0%)	0
Injury, poisoning and procedural complications
Hospitalization due to concussion with subdural hematoma	1/403 (0.2%)	1	0/197 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/403 (0.2%)	1	0/197 (0%)	0
Liver cancer	1/403 (0.2%)	1	0/197 (0%)	0
Malignant neuroendocrine tumors	0/403 (0%)	0	1/197 (0.5%)	1
Nervous system disorders
Anxiety	1/403 (0.2%)	1	0/197 (0%)	0
Renal and urinary disorders
Kidney disease	1/403 (0.2%)	1	0/197 (0%)	0
Respiratory, thoracic and mediastinal disorders
COPD	1/403 (0.2%)	1	0/197 (0%)	0
Hospitalization due to emphysema/COPD	1/403 (0.2%)	1	0/197 (0%)	0
Vascular disorders
Broken blood vessel in brain	0/403 (0%)	0	1/197 (0.5%)	1
Stroke	2/403 (0.5%)	2	0/197 (0%)	0
Transient ischemic attack	0/403 (0%)	0	1/197 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Light Adjustable Lens		Monofocal Control IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	292/403 (72.5%)		125/197 (63.5%)
Eye disorders
Anterior chamber cells	43/403 (10.7%)	43	21/197 (10.7%)	21
Anterior chamber flare	19/403 (4.7%)	19	11/197 (5.6%)	11
Blurred vision	31/403 (7.7%)	31	19/197 (9.6%)	19
Corneal edema central	25/403 (6.2%)	25	13/197 (6.6%)	13
corneal edema wound	43/403 (10.7%)	43	14/197 (7.1%)	14
Posterior capsular opacity	51/403 (12.7%)	51	26/197 (13.2%)	26
Raised IOP not requiring treatment	32/403 (7.9%)	32	2/197 (1%)	2
Raised IOP requiring treatment	26/403 (6.5%)	26	14/197 (7.1%)	14
Superficial punctate keratitis	22/403 (5.5%)	22	5/197 (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.