Trial Outcomes & Findings for Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System (NCT NCT01261975)
NCT ID: NCT01261975
Last Updated: 2012-02-27
Results Overview
Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
12 weeks
Results posted on
2012-02-27
Participant Flow
This study was conducted at one clinical site in Europe. First participant was enrolled on 8/25/2009 and last participant exited the study on 4/27/2010. Study lasted six months for enrollment and three months for follow-up.
36 participants at least 50 years of age were enrolled in bilateral cataract surgery with phacoemulsification and intraocular lens implantation for the correction of aphakia. The Stellaris Vision Enhancement System was used for a 1.8mm Coaxial Micro-Incision procedure in one eye and a 2.75mm coaxial standard procedure in the contralateral eye.
Participant milestones
| Measure |
Cataract Surgery
Cataract surgery with phacoemulsification. Eligible patients were randomized to undergo cataract surgery using the 1.8 mm coaxial micro incision technique in either the right eye or the left eye. The fellow eye was assigned to undergo cataract surgery using the 2.75 mm standard incision. The Stellaris Vision Enhancement System was used for the surgery.
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|---|---|
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Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cataract Surgery
Cataract surgery with phacoemulsification. Eligible patients were randomized to undergo cataract surgery using the 1.8 mm coaxial micro incision technique in either the right eye or the left eye. The fellow eye was assigned to undergo cataract surgery using the 2.75 mm standard incision. The Stellaris Vision Enhancement System was used for the surgery.
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|---|---|
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Overall Study
Surgical complication
|
1
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Baseline Characteristics
Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Baseline characteristics by cohort
| Measure |
Cataract Surgery
n=36 Participants
Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System
|
|---|---|
|
Age, Customized
Aged 71 to 81 years
|
36 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)- Full analysis Set (FAS) Population
Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.
Outcome measures
| Measure |
Coaxial Micro-Incision Cataract Surgery
n=36 eyes
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
|
Coaxial Small-Incision Cataract Surgery
n=35 eyes
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
|---|---|---|
|
Refractive Stability
Visit 1
|
17 Eyes
|
23 Eyes
|
|
Refractive Stability
Visit 2
|
25 Eyes
|
25 Eyes
|
|
Refractive Stability
Visit 3
|
27 Eyes
|
27 Eyes
|
|
Refractive Stability
Visit 4
|
27 Eyes
|
28 Eyes
|
|
Refractive Stability
Visit 5
|
28 Eyes
|
30 Eyes
|
|
Refractive Stability
Visit 6
|
29 Eyes
|
31 Eyes
|
|
Refractive Stability
Visit 7
|
29 Eyes
|
33 Eyes
|
SECONDARY outcome
Timeframe: Visit 1, visit 2, visit 3, visit 4Population: Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population
Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity
Outcome measures
| Measure |
Coaxial Micro-Incision Cataract Surgery
n=36 eyes
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
|
Coaxial Small-Incision Cataract Surgery
n=35 eyes
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
|---|---|---|
|
Best Corrected Visual Acuity
Visit 1
|
-0.26 logMAR
Standard Deviation 0.24
|
-0.27 logMAR
Standard Deviation 0.29
|
|
Best Corrected Visual Acuity
Visit 2
|
-0.37 logMAR
Standard Deviation 0.22
|
-0.39 logMAR
Standard Deviation 0.26
|
|
Best Corrected Visual Acuity
Visit 3
|
-0.38 logMAR
Standard Deviation 0.20
|
-0.38 logMAR
Standard Deviation 0.27
|
|
Best Corrected Visual Acuity
Visit 4
|
-0.39 logMAR
Standard Deviation 0.24
|
-0.38 logMAR
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: visit 5, visit 6, visit 7, visit 8Population: Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population
Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.
Outcome measures
| Measure |
Coaxial Micro-Incision Cataract Surgery
n=35 eyes
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
|
Coaxial Small-Incision Cataract Surgery
n=35 eyes
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
|---|---|---|
|
Best Corrected Visual Acuity
Visit 5
|
-0.40 logMAR
Standard Deviation 0.22
|
-0.40 logMAR
Standard Deviation 0.27
|
|
Best Corrected Visual Acuity
Visit 6
|
-0.39 logMAR
Standard Deviation 0.24
|
-0.42 logMAR
Standard Deviation 0.27
|
|
Best Corrected Visual Acuity
Visit 7
|
-0.40 logMAR
Standard Deviation 0.24
|
-0.42 logMAR
Standard Deviation 0.26
|
|
Best Corrected Visual Acuity
Visit 8
|
-0.41 logMAR
Standard Deviation 0.22
|
-0.41 logMAR
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Visit 1, visit 2, visit 3, visit 4Population: Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Outcome measures
| Measure |
Coaxial Micro-Incision Cataract Surgery
n=36 eyes
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
|
Coaxial Small-Incision Cataract Surgery
n=35 eyes
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
|---|---|---|
|
Uncorrected Visual Acuity
Visit 1
|
-0.22 logMAR
Standard Deviation 0.32
|
-0.34 logMAR
Standard Deviation 0.31
|
|
Uncorrected Visual Acuity
Visit 2
|
-0.37 logMAR
Standard Deviation 0.29
|
-0.45 logMAR
Standard Deviation 0.31
|
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Uncorrected Visual Acuity
Visit 3
|
-0.37 logMAR
Standard Deviation 0.30
|
-0.41 logMAR
Standard Deviation 0.32
|
|
Uncorrected Visual Acuity
Visit 4
|
-0.36 logMAR
Standard Deviation 0.30
|
-0.46 logMAR
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: visit 5, visit 6, visit 7, visit 8Population: Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Outcome measures
| Measure |
Coaxial Micro-Incision Cataract Surgery
n=35 eyes
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
|
Coaxial Small-Incision Cataract Surgery
n=35 eyes
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
|---|---|---|
|
Uncorrected Visual Acuity
Visit 5
|
-0.36 logMAR
Standard Deviation 0.33
|
-0.48 logMAR
Standard Deviation 0.32
|
|
Uncorrected Visual Acuity
Visit 6
|
-0.35 logMAR
Standard Deviation 0.31
|
-0.47 logMAR
Standard Deviation 0.34
|
|
Uncorrected Visual Acuity
Visit 7
|
-0.36 logMAR
Standard Deviation 0.35
|
-0.49 logMAR
Standard Deviation 0.33
|
|
Uncorrected Visual Acuity
Visit 8
|
-0.38 logMAR
Standard Deviation 0.31
|
-0.51 logMAR
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Visits 1-3Population: Surgically Induced Astigmatism, FAS Population
Surgically induced astigmatism was presented in dioptres at each visit.
Outcome measures
| Measure |
Coaxial Micro-Incision Cataract Surgery
n=36 eyes
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
|
Coaxial Small-Incision Cataract Surgery
n=35 eyes
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
|---|---|---|
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Surgically Induced Astigmatism (SIA)
Visit 1
|
0.70 Dioptres
Standard Deviation 0.55
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0.80 Dioptres
Standard Deviation 0.49
|
|
Surgically Induced Astigmatism (SIA)
Visit 2
|
0.45 Dioptres
Standard Deviation 0.39
|
0.61 Dioptres
Standard Deviation 0.33
|
|
Surgically Induced Astigmatism (SIA)
Visit 3
|
0.41 Dioptres
Standard Deviation 0.21
|
0.60 Dioptres
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Visits 4-8Population: Surgically Induced Astigmatism-FAS Population
Surgically induced astigmatism presented in dioptres at each visit.
Outcome measures
| Measure |
Coaxial Micro-Incision Cataract Surgery
n=35 eyes
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
|
Coaxial Small-Incision Cataract Surgery
n=35 eyes
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
|---|---|---|
|
Surgically Induced Astigmatism (SIA)
Visit 4
|
0.44 Dioptres
Standard Deviation 0.37
|
0.52 Dioptres
Standard Deviation 0.31
|
|
Surgically Induced Astigmatism (SIA)
Visit 5
|
0.39 Dioptres
Standard Deviation 0.36
|
0.53 Dioptres
Standard Deviation 0.35
|
|
Surgically Induced Astigmatism (SIA)
Visit 6
|
0.37 Dioptres
Standard Deviation 0.27
|
0.59 Dioptres
Standard Deviation 0.30
|
|
Surgically Induced Astigmatism (SIA)
Visit 7
|
0.37 Dioptres
Standard Deviation 0.31
|
0.51 Dioptres
Standard Deviation 0.31
|
|
Surgically Induced Astigmatism (SIA)
Visit 8
|
0.37 Dioptres
Standard Deviation 0.21
|
0.42 Dioptres
Standard Deviation 0.26
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Adverse Events
Co-Axial Micro-Incision Cataract Surgery
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Coaxial Small-Incision Cataract Surgery
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Cataract Surgery All Participants
Serious events: 5 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Co-Axial Micro-Incision Cataract Surgery
n=36 participants at risk
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System.
|
Coaxial Small-Incision Cataract Surgery
n=35 participants at risk
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
Cataract Surgery All Participants
n=71 participants at risk；n=36 participants at risk
Events by participant one eye with 1.8 mm coaxial micro-incision cataract surgery (C-MICS) and the contralateral eye with the 2.75 mm coaxial standard cataract surgery.
|
|---|---|---|---|
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Eye disorders
Macular Degeneration
|
2.8%
1/36 • Number of events 1 • 12 Weeks
Safety Set
|
0.00%
0/35 • 12 Weeks
Safety Set
|
0.00%
0/36 • 12 Weeks
Safety Set
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/36 • 12 Weeks
Safety Set
|
0.00%
0/35 • 12 Weeks
Safety Set
|
2.8%
1/36 • Number of events 1 • 12 Weeks
Safety Set
|
|
Vascular disorders
High Blood Pressure
|
0.00%
0/36 • 12 Weeks
Safety Set
|
0.00%
0/35 • 12 Weeks
Safety Set
|
2.8%
1/36 • Number of events 1 • 12 Weeks
Safety Set
|
|
Musculoskeletal and connective tissue disorders
Hip Arthrosis
|
0.00%
0/36 • 12 Weeks
Safety Set
|
0.00%
0/35 • 12 Weeks
Safety Set
|
2.8%
1/36 • Number of events 1 • 12 Weeks
Safety Set
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Syndrome
|
0.00%
0/36 • 12 Weeks
Safety Set
|
0.00%
0/35 • 12 Weeks
Safety Set
|
2.8%
1/36 • Number of events 1 • 12 Weeks
Safety Set
|
|
Infections and infestations
Erysipelas
|
0.00%
0/36 • 12 Weeks
Safety Set
|
0.00%
0/35 • 12 Weeks
Safety Set
|
2.8%
1/36 • Number of events 1 • 12 Weeks
Safety Set
|
Other adverse events
| Measure |
Co-Axial Micro-Incision Cataract Surgery
n=36 participants at risk
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System.
|
Coaxial Small-Incision Cataract Surgery
n=35 participants at risk
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
|
Cataract Surgery All Participants
n=71 participants at risk；n=36 participants at risk
Events by participant one eye with 1.8 mm coaxial micro-incision cataract surgery (C-MICS) and the contralateral eye with the 2.75 mm coaxial standard cataract surgery.
|
|---|---|---|---|
|
Eye disorders
Anterior Chamber Cell
|
77.8%
28/36 • Number of events 30 • 12 Weeks
Safety Set
|
85.7%
30/35 • Number of events 32 • 12 Weeks
Safety Set
|
81.7%
58/71 • Number of events 62 • 12 Weeks
Safety Set
|
|
Eye disorders
Corneal Edema
|
58.3%
21/36 • Number of events 21 • 12 Weeks
Safety Set
|
62.9%
22/35 • Number of events 22 • 12 Weeks
Safety Set
|
60.6%
43/71 • Number of events 43 • 12 Weeks
Safety Set
|
|
Eye disorders
Anterior Chamber flare
|
22.2%
8/36 • Number of events 8 • 12 Weeks
Safety Set
|
22.9%
8/35 • Number of events 9 • 12 Weeks
Safety Set
|
22.5%
16/71 • Number of events 17 • 12 Weeks
Safety Set
|
|
Eye disorders
Visual Disturbance
|
11.1%
4/36 • Number of events 4 • 12 Weeks
Safety Set
|
5.7%
2/35 • Number of events 2 • 12 Weeks
Safety Set
|
8.5%
6/71 • Number of events 6 • 12 Weeks
Safety Set
|
|
Eye disorders
Posterior Capsule Opacification
|
5.6%
2/36 • Number of events 2 • 12 Weeks
Safety Set
|
5.7%
2/35 • Number of events 2 • 12 Weeks
Safety Set
|
5.6%
4/71 • Number of events 4 • 12 Weeks
Safety Set
|
|
Eye disorders
Conjunctivitis
|
5.6%
2/36 • Number of events 2 • 12 Weeks
Safety Set
|
2.9%
1/35 • Number of events 1 • 12 Weeks
Safety Set
|
4.2%
3/71 • Number of events 3 • 12 Weeks
Safety Set
|
|
Eye disorders
Blurred Vision
|
5.6%
2/36 • Number of events 2 • 12 Weeks
Safety Set
|
2.9%
1/35 • Number of events 1 • 12 Weeks
Safety Set
|
4.2%
3/71 • Number of events 3 • 12 Weeks
Safety Set
|
|
Eye disorders
Vitreous Detachment
|
5.6%
2/36 • Number of events 2 • 12 Weeks
Safety Set
|
0.00%
0/35 • 12 Weeks
Safety Set
|
2.8%
2/71 • Number of events 2 • 12 Weeks
Safety Set
|
|
Eye disorders
Increased Intraocular Pressure
|
13.9%
5/36 • Number of events 5 • 12 Weeks
Safety Set
|
11.4%
4/35 • Number of events 4 • 12 Weeks
Safety Set
|
12.7%
9/71 • Number of events 9 • 12 Weeks
Safety Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER