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The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Experimental | 1.8 mm coaxial microincision |
|
| Coaxial Small Incision Cataract Surgery | Active Comparator | 2.75 mm standard incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaxial Micro-Incision Cataract Surgery | Procedure | 1.8 mm coaxial micro incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Refractive Stability | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | 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 | Visit 1, visit 2, visit 3, visit 4 |
| Best Corrected Visual Acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Williart, MD | Bausch & Lomb Incorporated | Study Director |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cataract Surgery | Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Refractive Stability | 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. | Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)- Full analysis Set (FAS) Population | Posted | Number | Eyes | 12 weeks | eyes | Participants |
|
12 Weeks
Safety Set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Co-Axial Micro-Incision Cataract Surgery | 1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular Degeneration | Eye disorders | MedDRA (11.0) | Systematic Assessment | Pre-existing condition |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Chamber Cell | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Omid Khodai | Bausch & Lomb | (949) 521-7894 | Omid.Khodai@bausch.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Coaxial Small Incision Cataract Surgery | Procedure | 2.75 mm coaxial incision |
|
|
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. |
| visit 5, visit 6, visit 7, visit 8 |
| Uncorrected Visual Acuity | Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit. | Visit 1, visit 2, visit 3, visit 4 |
| Uncorrected Visual Acuity | Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit. | visit 5, visit 6, visit 7, visit 8 |
| Surgically Induced Astigmatism (SIA) | Surgically induced astigmatism was presented in dioptres at each visit. | Visits 1-3 |
| Surgically Induced Astigmatism (SIA) | Surgically induced astigmatism presented in dioptres at each visit. | Visits 4-8 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Best Corrected Visual Acuity | 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 | Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population | Posted | Mean | Standard Deviation | logMAR | Visit 1, visit 2, visit 3, visit 4 | eyes | Participants |
|
|
|
| Secondary | Best Corrected Visual Acuity | 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. | Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population | Posted | Mean | Standard Deviation | logMAR | visit 5, visit 6, visit 7, visit 8 | eyes | Participants |
|
|
|
| Secondary | Uncorrected Visual Acuity | Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit. | Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population | Posted | Mean | Standard Deviation | logMAR | Visit 1, visit 2, visit 3, visit 4 | eyes | Participants |
|
|
|
| Secondary | Uncorrected Visual Acuity | Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit. | Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population | Posted | Mean | Standard Deviation | logMAR | visit 5, visit 6, visit 7, visit 8 | eyes | Participants |
|
|
|
| Secondary | Surgically Induced Astigmatism (SIA) | Surgically induced astigmatism was presented in dioptres at each visit. | Surgically Induced Astigmatism, FAS Population | Posted | Mean | Standard Deviation | Dioptres | Visits 1-3 | eyes | Participants |
|
|
|
| Secondary | Surgically Induced Astigmatism (SIA) | Surgically induced astigmatism presented in dioptres at each visit. | Surgically Induced Astigmatism-FAS Population | Posted | Mean | Standard Deviation | Dioptres | Visits 4-8 | eyes | Participants |
|
|
|
| 1 |
| 36 |
| 33 |
| 36 |
| EG001 | Coaxial Small-Incision Cataract Surgery | 2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System. | 0 | 35 | 33 | 35 |
| EG002 | Cataract Surgery All Participants | 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. | 5 | 36 | 66 | 71 |
|
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment | Unrelated to study, crossed both arms, non ocular SAE |
|
| High Blood Pressure | Vascular disorders | MedDRA (11.0) | Systematic Assessment | Unrelated to study, crossed both arms, non ocular SAE |
|
| Hip Arthrosis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment | Unrelated to study, crossed both arms, non ocular SAE |
|
| Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment | Unrelated to study, crossed both arms, non ocular SAE |
|
| Erysipelas | Infections and infestations | MedDRA (11.0) | Systematic Assessment | Unrelated to study, crossed both arms, non ocular SAE |
|
| Corneal Edema | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Anterior Chamber flare | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Visual Disturbance | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Posterior Capsule Opacification | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Blurred Vision | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vitreous Detachment | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Increased Intraocular Pressure | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
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.
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