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Trial record 8 of 103 for:    cataract AND Astigmatism

Toric Intraocular Lens Following Cataract Surgery

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: NCT01140477
Recruitment Status : Completed
First Posted : June 9, 2010
Results First Posted : August 22, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Cataract
Astigmatism
Interventions Device: Toric Accommodating Lens
Device: Accommodating Lens
Enrollment 229
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Crystalens Toric IOL Crystalens IOL
Hide 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
Reason Not Completed
Lost to Follow-up             4             0
Withdrawal by Subject             1             4
Surgical complication preventing implant             2             0
Death             1             1
Subject explanted             0             1
Arm/Group Title Crystalens Toric IOL Crystalens IOL Total
Hide 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 Number of Baseline Participants 153 76 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 153 participants 76 participants 229 participants
70.1
(48 to 89)
69.8
(47 to 89)
70.0
(47 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 76 participants 229 participants
Female
81
  52.9%
42
  55.3%
123
  53.7%
Male
72
  47.1%
34
  44.7%
106
  46.3%
1.Primary Outcome
Title Percent Reduction in Absolute Cylinder
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 134 68
Mean (95% Confidence Interval)
Unit of Measure: percentage of intended cylinder reduct
84.975
(79.961 to 89.989)
46.498
(35.891 to 57.105)
2.Secondary Outcome
Title Lens Misalignment
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: degrees
4.660  (4.208)
3.Secondary Outcome
Title Visual Acuity
Hide Description Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
Time Frame 120 - 180 day postoperative visit
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 134 68
Mean (Standard Deviation)
Unit of Measure: logMAR
0.004  (0.097) 0.012  (0.094)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Crystalens Toric IOL Crystalens IOL
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Crystalens Toric IOL Crystalens IOL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/153 (10.46%)      6/76 (7.89%)    
Blood and lymphatic system disorders     
Bronchopulmonary aspergillosis allergic   1/153 (0.65%)  1 0/76 (0.00%)  0
High grade B-cell lymphoma, Burkitt-like lymphoma   1/153 (0.65%)  1 0/76 (0.00%)  0
Cardiac disorders     
Atrial fibrillation   1/153 (0.65%)  1 0/76 (0.00%)  0
Atrial flutter   1/153 (0.65%)  1 0/76 (0.00%)  0
Cardiac arrest   1/153 (0.65%)  1 0/76 (0.00%)  0
Cardiac disorder   1/153 (0.65%)  1 0/76 (0.00%)  0
Cardiac failure congestive   1/153 (0.65%)  1 0/76 (0.00%)  0
Coronary artery disease   1/153 (0.65%)  2 0/76 (0.00%)  0
Myocardial infarction   1/153 (0.65%)  1 0/76 (0.00%)  0
Eye disorders     
Optic neuropathy   1/153 (0.65%)  1 0/76 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal haemorrhage   1/153 (0.65%)  1 0/76 (0.00%)  0
Gastrointestinal ulcer haemorrhage   1/153 (0.65%)  1 0/76 (0.00%)  0
General disorders     
Death   0/153 (0.00%)  0 1/76 (1.32%)  1
Device dislocation   2/153 (1.31%)  2 0/76 (0.00%)  0
Infections and infestations     
Cystitis   1/153 (0.65%)  1 0/76 (0.00%)  0
Pneumonia   1/153 (0.65%)  1 0/76 (0.00%)  0
Injury, poisoning and procedural complications     
Cataract operation complication   0/153 (0.00%)  0 2/76 (2.63%)  2
Musculoskeletal and connective tissue disorders     
Bone sarcoma   0/153 (0.00%)  0 1/76 (1.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant   0/153 (0.00%)  0 1/76 (1.32%)  1
Prostate cancer   1/153 (0.65%)  1 0/76 (0.00%)  0
Nervous system disorders     
Transient ischaemic attack   1/153 (0.65%)  1 0/76 (0.00%)  0
Renal and urinary disorders     
Renal artery stenosis   0/153 (0.00%)  0 1/76 (1.32%)  1
Vascular disorders     
Aortic aneurysm   0/153 (0.00%)  0 1/76 (1.32%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Crystalens Toric IOL Crystalens IOL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/153 (30.72%)      29/76 (38.16%)    
Eye disorders     
Dry eye   14/153 (9.15%)  26 3/76 (3.95%)  6
Vitreous detachment   17/153 (11.11%)  24 5/76 (6.58%)  8
Blepharitis   9/153 (5.88%)  17 4/76 (5.26%)  11
Corneal oedema   10/153 (6.54%)  16 2/76 (2.63%)  2
Keratoconjunctivitis sicca   6/153 (3.92%)  9 9/76 (11.84%)  15
Conjunctivitis allergic   3/153 (1.96%)  5 6/76 (7.89%)  10
Punctate keratitis   6/153 (3.92%)  9 4/76 (5.26%)  7
Vitreous floaters   6/153 (3.92%)  10 6/76 (7.89%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
Name/Title: Johnson Varughese
Organization: Bausch & Lomb, a division of Valeant Corporation
Phone: 908-541-2179
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01140477     History of Changes
Other Study ID Numbers: 650
First Submitted: June 8, 2010
First Posted: June 9, 2010
Results First Submitted: August 7, 2014
Results First Posted: August 22, 2014
Last Update Posted: September 8, 2014