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To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phaco | Active Comparator | Cataract extraction surgery utilizing Phacoemulsification |
|
| SICS | Active Comparator | Small incision cataract surgery (SICS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phacoemulsification cataract extraction surgery | Procedure | Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF) |
| Measure | Description | Time Frame |
|---|---|---|
| Posterior Capsule Opacification Evaluation | The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better. | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Astigmatism | Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better. | 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center | Fort Worth | Texas | 76134 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phaco | cataract extraction surgery utilizing Phacoemulsification |
| FG001 | SICS | Small incision cataract surgery (SICS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phaco | cataract extraction surgery utilizing Phacoemulsification |
| BG001 | SICS | Small incision cataract surgery (SICS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Posterior Capsule Opacification Evaluation | The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better. | Posted | Number | participants | 12 months after surgery |
|
During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
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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 | Phaco | cataract extraction surgery utilizing Phacoemulsification |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior Capsular Rupture | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Small incision cataract surgery | Procedure | Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD). |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Corneal Astigmatism | Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better. | Posted | Mean | Standard Deviation | Diopters | 3 months after surgery |
|
|
|
| 0 |
| 55 |
| 2 |
| 55 |
| EG001 | SICS | Small incision cataract surgery (SICS) | 0 | 51 | 6 | 51 |
| Conjunctival Congestion | Eye disorders |
|
| Femoral Fracture | Musculoskeletal and connective tissue disorders |
|
| Zonular Rupture | Eye disorders |
|
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