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Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

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ClinicalTrials.gov Identifier: NCT01261975
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : February 27, 2012
Last Update Posted : February 27, 2012
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
Aphakia
Interventions Procedure: Coaxial Micro-Incision Cataract Surgery
Procedure: Coaxial Small Incision Cataract Surgery
Enrollment 36
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Cataract Surgery
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 36 [1]
Completed 35 [2]
Not Completed 1
Reason Not Completed
Surgical complication             1
[1]
36 Participants 72 eyes started
[2]
35 Participants 70 eyes completed
Arm/Group Title Cataract Surgery
Hide Arm/Group Description Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Aged 71 to 81 years Number Analyzed 36 participants
36
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
25
  69.4%
Male
11
  30.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Europe Number Analyzed 36 participants
36
1.Primary Outcome
Title Refractive Stability
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)— Full analysis Set (FAS) Population
Arm/Group Title Coaxial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery
Hide Arm/Group Description:
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
Overall Number of Participants Analyzed 36 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
36 35
Measure Type: Number
Unit of Measure: Eyes
Visit 1 17 23
Visit 2 25 25
Visit 3 27 27
Visit 4 27 28
Visit 5 28 30
Visit 6 29 31
Visit 7 29 33
2.Secondary Outcome
Title Best Corrected Visual Acuity
Hide Description 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
Time Frame Visit 1, visit 2, visit 3, visit 4
Hide Outcome Measure Data
Hide Analysis Population Description
Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population
Arm/Group Title Coaxial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery
Hide Arm/Group Description:
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
Overall Number of Participants Analyzed 36 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
36 35
Mean (Standard Deviation)
Unit of Measure: logMAR
Visit 1 -0.26  (0.24) -0.27  (0.29)
Visit 2 -0.37  (0.22) -0.39  (0.26)
Visit 3 -0.38  (0.20) -0.38  (0.27)
Visit 4 -0.39  (0.24) -0.38  (0.27)
3.Secondary Outcome
Title Best Corrected Visual Acuity
Hide Description 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.
Time Frame visit 5, visit 6, visit 7, visit 8
Hide Outcome Measure Data
Hide Analysis Population Description
Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population
Arm/Group Title Coaxial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery
Hide Arm/Group Description:
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
Overall Number of Participants Analyzed 35 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
35 35
Mean (Standard Deviation)
Unit of Measure: logMAR
Visit 5 -0.40  (0.22) -0.40  (0.27)
Visit 6 -0.39  (0.24) -0.42  (0.27)
Visit 7 -0.40  (0.24) -0.42  (0.26)
Visit 8 -0.41  (0.22) -0.41  (0.28)
4.Secondary Outcome
Title Uncorrected Visual Acuity
Hide Description Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Time Frame Visit 1, visit 2, visit 3, visit 4
Hide Outcome Measure Data
Hide Analysis Population Description
Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population
Arm/Group Title Coaxial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery
Hide Arm/Group Description:
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
Overall Number of Participants Analyzed 36 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
36 35
Mean (Standard Deviation)
Unit of Measure: logMAR
Visit 1 -0.22  (0.32) -0.34  (0.31)
Visit 2 -0.37  (0.29) -0.45  (0.31)
Visit 3 -0.37  (0.30) -0.41  (0.32)
Visit 4 -0.36  (0.30) -0.46  (0.31)
5.Secondary Outcome
Title Uncorrected Visual Acuity
Hide Description Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Time Frame visit 5, visit 6, visit 7, visit 8
Hide Outcome Measure Data
Hide Analysis Population Description
Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population
Arm/Group Title Coaxial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery
Hide Arm/Group Description:
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
Overall Number of Participants Analyzed 35 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
35 35
Mean (Standard Deviation)
Unit of Measure: logMAR
Visit 5 -0.36  (0.33) -0.48  (0.32)
Visit 6 -0.35  (0.31) -0.47  (0.34)
Visit 7 -0.36  (0.35) -0.49  (0.33)
Visit 8 -0.38  (0.31) -0.51  (0.32)
6.Secondary Outcome
Title Surgically Induced Astigmatism (SIA)
Hide Description Surgically induced astigmatism was presented in dioptres at each visit.
Time Frame Visits 1-3
Hide Outcome Measure Data
Hide Analysis Population Description
Surgically Induced Astigmatism, FAS Population
Arm/Group Title Coaxial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery
Hide Arm/Group Description:
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
Overall Number of Participants Analyzed 36 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
36 35
Mean (Standard Deviation)
Unit of Measure: Dioptres
Visit 1 0.70  (0.55) 0.80  (0.49)
Visit 2 0.45  (0.39) 0.61  (0.33)
Visit 3 0.41  (0.21) 0.60  (0.31)
7.Secondary Outcome
Title Surgically Induced Astigmatism (SIA)
Hide Description Surgically induced astigmatism presented in dioptres at each visit.
Time Frame Visits 4-8
Hide Outcome Measure Data
Hide Analysis Population Description
Surgically Induced Astigmatism—FAS Population
Arm/Group Title Coaxial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery
Hide Arm/Group Description:
1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
Overall Number of Participants Analyzed 35 35
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
35 35
Mean (Standard Deviation)
Unit of Measure: Dioptres
Visit 4 0.44  (0.37) 0.52  (0.31)
Visit 5 0.39  (0.36) 0.53  (0.35)
Visit 6 0.37  (0.27) 0.59  (0.30)
Visit 7 0.37  (0.31) 0.51  (0.31)
Visit 8 0.37  (0.21) 0.42  (0.26)
Time Frame 12 Weeks
Adverse Event Reporting Description Safety Set
 
Arm/Group Title Co-Axial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery Cataract Surgery All Participants
Hide Arm/Group Description 1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System. 2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System. 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.
All-Cause Mortality
Co-Axial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery Cataract Surgery All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Co-Axial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery Cataract Surgery All Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/36 (2.78%)      0/35 (0.00%)      5/36 (13.89%)    
Eye disorders       
Macular Degeneration  1 [1]  1/36 (2.78%)  1 0/35 (0.00%)  0 0/36 (0.00%)  0
Infections and infestations       
Erysipelas  1 [2]  0/36 (0.00%)  0 0/35 (0.00%)  0 1/36 (2.78%)  1
Musculoskeletal and connective tissue disorders       
Hip Arthrosis  1 [2]  0/36 (0.00%)  0 0/35 (0.00%)  0 1/36 (2.78%)  1
Carpal Tunnel Syndrome  1 [2]  0/36 (0.00%)  0 0/35 (0.00%)  0 1/36 (2.78%)  1
Renal and urinary disorders       
Urinary Tract Infection  1 [2]  0/36 (0.00%)  0 0/35 (0.00%)  0 1/36 (2.78%)  1
Vascular disorders       
High Blood Pressure  1 [2]  0/36 (0.00%)  0 0/35 (0.00%)  0 1/36 (2.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
[1]
Pre-existing condition
[2]
Unrelated to study, crossed both arms, non ocular SAE
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Co-Axial Micro-Incision Cataract Surgery Coaxial Small-Incision Cataract Surgery Cataract Surgery All Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/36 (91.67%)      33/35 (94.29%)      66/71 (92.96%)    
Eye disorders       
Anterior Chamber Cell  1  28/36 (77.78%)  30 30/35 (85.71%)  32 58/71 (81.69%)  62
Corneal Edema  1  21/36 (58.33%)  21 22/35 (62.86%)  22 43/71 (60.56%)  43
Anterior Chamber flare  1  8/36 (22.22%)  8 8/35 (22.86%)  9 16/71 (22.54%)  17
Visual Disturbance  1  4/36 (11.11%)  4 2/35 (5.71%)  2 6/71 (8.45%)  6
Posterior Capsule Opacification  1  2/36 (5.56%)  2 2/35 (5.71%)  2 4/71 (5.63%)  4
Conjunctivitis  1  2/36 (5.56%)  2 1/35 (2.86%)  1 3/71 (4.23%)  3
Blurred Vision  1  2/36 (5.56%)  2 1/35 (2.86%)  1 3/71 (4.23%)  3
Vitreous Detachment  1  2/36 (5.56%)  2 0/35 (0.00%)  0 2/71 (2.82%)  2
Increased Intraocular Pressure  1  5/36 (13.89%)  5 4/35 (11.43%)  4 9/71 (12.68%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
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.
Results Point of Contact
Name/Title: Omid Khodai
Organization: Bausch & Lomb
Phone: (949) 521-7894
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01261975     History of Changes
Other Study ID Numbers: 607
First Submitted: December 15, 2010
First Posted: December 17, 2010
Results First Submitted: September 21, 2011
Results First Posted: February 27, 2012
Last Update Posted: February 27, 2012