Toric Intraocular Lens Following Cataract Surgery

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01140477
• Collaborator: (none)
• Enrollment: 229
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Astigmatism	Device: Toric Accommodating Lens; Device: Accommodating Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 229 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Multicenter Clinical Trial To Evaluate the Effectiveness of A Toric Accommodating Posterior Chamber Silicone Intraocular Lens Designed To Provide Near, Intermediate, And Distance Vision And Reduce The Effects Of Preoperative Corneal Astigmatism On Postoperative Refraction Following Cataract Surgery
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crystalens toric IOL Toric Accommodating Lens Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)	Device: Toric Accommodating Lens; Toric accommodating lens implanted after cataract extraction
Active Comparator: Crystalens IOL Accommodating Lens Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)	Device: Accommodating Lens; Accommodating lens implanted after cataract extraction

Outcome Measures

Primary Outcome Measures

1. Percent Reduction in Absolute Cylinder [120 - 180 day postoperative visit]

   Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.

Secondary Outcome Measures

1. Lens Misalignment [120 - 180 day postoperative visit]

   This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.

2. Visual Acuity [120 - 180 day postoperative visit]

   Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have a clinically documented diagnosis of age-related cataract

• Subjects must require a lens power from 16 to 27 diopters

• Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator

Exclusion Criteria:

• Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated.

• Subjects with diagnoses of degenerative visual disorders.

• Subjects with conditions associated with increased risk of zonular rupture.

• Subjects who have had previous corneal surgery in the planned operative eye.

• Subjects with irregular corneal astigmatism.

• Subjects with clinically significant retinal pigment or epithelium/macular changes.

• Subjects with chronic use of systemic steroids or immunosuppressive medications.

• Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study.

• Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	B&L Surgical	Bridgewater	New Jersey	United States	08807

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Jay Pepose, MD, PhD, Pepose Vision Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01140477
• Other Study ID Numbers: 650
• First Posted: Jun 9, 2010
• Last Update Posted: Sep 8, 2014
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Cataract; Astigmatism

Study Results

Participant Flow

Arm/Group Title	Crystalens Toric IOL	Crystalens IOL
Arm/Group Description	Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)	Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Period Title: Overall Study
STARTED	153	76
COMPLETED	145	70
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	Crystalens Toric IOL	Crystalens IOL	Total
Arm/Group Description	Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)	Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)	Total of all reporting groups
Overall Participants	153	76	229
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	70.1 (9.0)	69.8 (9.2)	70.0
Sex: Female, Male (Count of Participants)
Female	81 52.9%	42 55.3%	123 53.7%
Male	72 47.1%	34 44.7%	106 46.3%

Outcome Measures

1. Primary Outcome

Title	Percent Reduction in Absolute Cylinder
Description	Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.
Time Frame	120 - 180 day postoperative visit

Outcome Measure Data

Analysis Population Description

The analysis population only includes those for whom the outcome was measured within the specified time frame.

Arm/Group Title	Crystalens Toric IOL	Crystalens IOL
Arm/Group Description	Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction	Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) Accommodating Lens: Accommodating lens implanted during cataract extraction
Measure Participants	134	68
Mean (95% Confidence Interval) [percentage of intended cylinder reduct]	84.975	46.498

2. Secondary Outcome

Title	Lens Misalignment
Description	This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.
Time Frame	120 - 180 day postoperative visit

Outcome Measure Data

Analysis Population Description

The analysis population only includes those for whom the outcome was measured within the specified time frame.

Arm/Group Title	Crystalens Toric IOL
Arm/Group Description	Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction
Measure Participants	130
Mean (Standard Deviation) [degrees]	4.660 (4.208)

3. Secondary Outcome

Title	Visual Acuity
Description	Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
Time Frame	120 - 180 day postoperative visit

Outcome Measure Data

Analysis Population Description

The analysis population only includes those for whom the outcome was measured within the specified time frame.

Arm/Group Title	Crystalens Toric IOL	Crystalens IOL
Arm/Group Description	Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction	Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) Accommodating Lens: Accommodating lens implanted during cataract extraction
Measure Participants	134	68
Mean (Standard Deviation) [logMAR]	0.004 (0.097)	0.012 (0.094)

Adverse Events

Arm/Group Title	Crystalens Toric IOL		Crystalens IOL
Arm/Group Description	Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T) Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction		Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE) Accommodating Lens: Accommodating lens implanted during cataract extraction
All Cause Mortality
	Crystalens Toric IOL		Crystalens IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Crystalens Toric IOL		Crystalens IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/153 (10.5%)		6/76 (7.9%)
Blood and lymphatic system disorders
Bronchopulmonary aspergillosis allergic	1/153 (0.7%)	1	0/76 (0%)	0
High grade B-cell lymphoma, Burkitt-like lymphoma	1/153 (0.7%)	1	0/76 (0%)	0
Cardiac disorders
Atrial fibrillation	1/153 (0.7%)	1	0/76 (0%)	0
Atrial flutter	1/153 (0.7%)	1	0/76 (0%)	0
Cardiac arrest	1/153 (0.7%)	1	0/76 (0%)	0
Cardiac disorder	1/153 (0.7%)	1	0/76 (0%)	0
Cardiac failure congestive	1/153 (0.7%)	1	0/76 (0%)	0
Coronary artery disease	1/153 (0.7%)	2	0/76 (0%)	0
Myocardial infarction	1/153 (0.7%)	1	0/76 (0%)	0
Eye disorders
Optic neuropathy	1/153 (0.7%)	1	0/76 (0%)	0
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/153 (0.7%)	1	0/76 (0%)	0
Gastrointestinal ulcer haemorrhage	1/153 (0.7%)	1	0/76 (0%)	0
General disorders
Death	0/153 (0%)	0	1/76 (1.3%)	1
Device dislocation	2/153 (1.3%)	2	0/76 (0%)	0
Infections and infestations
Cystitis	1/153 (0.7%)	1	0/76 (0%)	0
Pneumonia	1/153 (0.7%)	1	0/76 (0%)	0
Injury, poisoning and procedural complications
Cataract operation complication	0/153 (0%)	0	2/76 (2.6%)	2
Musculoskeletal and connective tissue disorders
Bone sarcoma	0/153 (0%)	0	1/76 (1.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	0/153 (0%)	0	1/76 (1.3%)	1
Prostate cancer	1/153 (0.7%)	1	0/76 (0%)	0
Nervous system disorders
Transient ischaemic attack	1/153 (0.7%)	1	0/76 (0%)	0
Renal and urinary disorders
Renal artery stenosis	0/153 (0%)	0	1/76 (1.3%)	1
Vascular disorders
Aortic aneurysm	0/153 (0%)	0	1/76 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Crystalens Toric IOL		Crystalens IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/153 (30.7%)		29/76 (38.2%)
Eye disorders
Dry eye	14/153 (9.2%)	26	3/76 (3.9%)	6
Vitreous detachment	17/153 (11.1%)	24	5/76 (6.6%)	8
Blepharitis	9/153 (5.9%)	17	4/76 (5.3%)	11
Corneal oedema	10/153 (6.5%)	16	2/76 (2.6%)	2
Keratoconjunctivitis sicca	6/153 (3.9%)	9	9/76 (11.8%)	15
Conjunctivitis allergic	3/153 (2%)	5	6/76 (7.9%)	10
Punctate keratitis	6/153 (3.9%)	9	4/76 (5.3%)	7
Vitreous floaters	6/153 (3.9%)	10	6/76 (7.9%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

For a period of ten years, the PI agrees to keep confidential and not disclose, without the prior written consent of Sponsor, to any third party or use any technology, data, reports, results of clinical studies conducted under this Study or other information received by Sponsor, or any technology, data, reports, study materials, or other information developed by Sponsor unless disclosure by PI is required by law.