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| ID | Type | Description | Link |
|---|---|---|---|
| OculusGen-2007-04-20 | Other Identifier | Aeon Astron Europe B.V. |
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ologen collagen matrix is applied for the phacotrabec surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OculusGen Collagen Matrix | OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OculusGen Biodegradable Collagen Matrix Implant | Device | OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative and Postoperative Intraocular Pressure | The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days. | baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Complications or Adverse Events. | Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis. | 180 day |
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Subject inclusion criteria:
Subject exclusion criteria:
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10
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| Name | Affiliation | Role |
|---|---|---|
| SPS Grewal, MD | Grewal Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grewal Eye Institute | Chandigarh | 500 034 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17122118 | Result | Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. doi: 10.1167/iovs.06-0378. | |
| 10937547 | Result | Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OculusGen Collagen Matrix | OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OculusGen Collagen Matrix | OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy. |
| 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Any Complications or Adverse Events. | Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis. | Posted | Number | participants | 180 day |
|
|
Up to 90 days after surgery.
To assess if there was any complications or adverse events, including shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis in any patients.
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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 | OculusGen Collagen Matrix | OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy. |
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Limited sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| S.P.S Grewal, MD | Grewal Eye Institute | +91-172-5056969 | drgrewal@gmail.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Preoperative and Postoperative Intraocular Pressure | The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days. | Posted | Mean | Standard Deviation | mm Hg | baseline and 90 days |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
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