Trial Outcomes & Findings for Toric Intraocular Lens Following Cataract Surgery (NCT NCT01140477)
NCT ID: NCT01140477
Last Updated: 2014-09-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
229 participants
Primary outcome timeframe
120 - 180 day postoperative visit
Results posted on
2014-09-08
Participant Flow
Participant milestones
| Measure |
Crystalens Toric IOL
Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
|
Crystalens IOL
Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
76
|
|
Overall Study
COMPLETED
|
145
|
70
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Crystalens Toric IOL
Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
|
Crystalens IOL
Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Surgical complication preventing implant
|
2
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Subject explanted
|
0
|
1
|
Baseline Characteristics
Toric Intraocular Lens Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
Crystalens Toric IOL
n=153 Participants
Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
|
Crystalens IOL
n=76 Participants
Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.1 years
FULL_RANGE 9.0 • n=5 Participants
|
69.8 years
FULL_RANGE 9.2 • n=7 Participants
|
70.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 - 180 day postoperative visitPopulation: The analysis population only includes those for whom the outcome was measured within the specified time frame.
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.
Outcome measures
| Measure |
Crystalens Toric IOL
n=134 Participants
Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction
|
Crystalens IOL
n=68 Participants
Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Accommodating Lens: Accommodating lens implanted during cataract extraction
|
|---|---|---|
|
Percent Reduction in Absolute Cylinder
|
84.975 percentage of intended cylinder reduct
Interval 79.961 to 89.989
|
46.498 percentage of intended cylinder reduct
Interval 35.891 to 57.105
|
SECONDARY outcome
Timeframe: 120 - 180 day postoperative visitPopulation: The analysis population only includes those for whom the outcome was measured within the specified time frame.
This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.
Outcome measures
| Measure |
Crystalens Toric IOL
n=130 Participants
Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction
|
Crystalens IOL
Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Accommodating Lens: Accommodating lens implanted during cataract extraction
|
|---|---|---|
|
Lens Misalignment
|
4.660 degrees
Standard Deviation 4.208
|
—
|
SECONDARY outcome
Timeframe: 120 - 180 day postoperative visitPopulation: The analysis population only includes those for whom the outcome was measured within the specified time frame.
Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)
Outcome measures
| Measure |
Crystalens Toric IOL
n=134 Participants
Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction
|
Crystalens IOL
n=68 Participants
Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Accommodating Lens: Accommodating lens implanted during cataract extraction
|
|---|---|---|
|
Visual Acuity
|
0.004 logMAR
Standard Deviation 0.097
|
0.012 logMAR
Standard Deviation 0.094
|
Adverse Events
Crystalens Toric IOL
Serious events: 16 serious events
Other events: 47 other events
Deaths: 0 deaths
Crystalens IOL
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Crystalens Toric IOL
n=153 participants at risk
Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction
|
Crystalens IOL
n=76 participants at risk
Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Accommodating Lens: Accommodating lens implanted during cataract extraction
|
|---|---|---|
|
Blood and lymphatic system disorders
Bronchopulmonary aspergillosis allergic
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Blood and lymphatic system disorders
High grade B-cell lymphoma, Burkitt-like lymphoma
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Cardiac disorders
Atrial flutter
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Cardiac disorders
Cardiac arrest
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Cardiac disorders
Cardiac disorder
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Cardiac disorders
Cardiac failure congestive
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Cardiac disorders
Coronary artery disease
|
0.65%
1/153 • Number of events 2
|
0.00%
0/76
|
|
Cardiac disorders
Myocardial infarction
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Eye disorders
Optic neuropathy
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
General disorders
Death
|
0.00%
0/153
|
1.3%
1/76 • Number of events 1
|
|
General disorders
Device dislocation
|
1.3%
2/153 • Number of events 2
|
0.00%
0/76
|
|
Infections and infestations
Cystitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Infections and infestations
Pneumonia
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/153
|
2.6%
2/76 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone sarcoma
|
0.00%
0/153
|
1.3%
1/76 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/153
|
1.3%
1/76 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Nervous system disorders
Transient ischaemic attack
|
0.65%
1/153 • Number of events 1
|
0.00%
0/76
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/153
|
1.3%
1/76 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/153
|
1.3%
1/76 • Number of events 1
|
Other adverse events
| Measure |
Crystalens Toric IOL
n=153 participants at risk
Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction
|
Crystalens IOL
n=76 participants at risk
Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
Accommodating Lens: Accommodating lens implanted during cataract extraction
|
|---|---|---|
|
Eye disorders
Dry eye
|
9.2%
14/153 • Number of events 26
|
3.9%
3/76 • Number of events 6
|
|
Eye disorders
Vitreous detachment
|
11.1%
17/153 • Number of events 24
|
6.6%
5/76 • Number of events 8
|
|
Eye disorders
Blepharitis
|
5.9%
9/153 • Number of events 17
|
5.3%
4/76 • Number of events 11
|
|
Eye disorders
Corneal oedema
|
6.5%
10/153 • Number of events 16
|
2.6%
2/76 • Number of events 2
|
|
Eye disorders
Keratoconjunctivitis sicca
|
3.9%
6/153 • Number of events 9
|
11.8%
9/76 • Number of events 15
|
|
Eye disorders
Conjunctivitis allergic
|
2.0%
3/153 • Number of events 5
|
7.9%
6/76 • Number of events 10
|
|
Eye disorders
Punctate keratitis
|
3.9%
6/153 • Number of events 9
|
5.3%
4/76 • Number of events 7
|
|
Eye disorders
Vitreous floaters
|
3.9%
6/153 • Number of events 10
|
7.9%
6/76 • Number of events 7
|
Additional Information
Johnson Varughese
Bausch & Lomb, a division of Valeant Corporation
Phone: 908-541-2179
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER