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To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.
To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MITOMYCIN-C | Active Comparator | Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C. |
|
| ologen (Oculusgen) | Experimental | 20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Matrix in Glaucoma Filtering Surgery | Device | Collagen Matrix implantation in Glaucoma Filtering Surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Intraocular Pressure Change | Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. | 360 days |
| Postoperative Intraocular Pressure Change | Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. | 180 days |
| Postoperative Intraocular Pressure Change | Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. | 90 days |
| Postoperative Intraocular Pressure Change | Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days. | 360 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Dietlein, Ph. D, MD | Universität Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Universität Köln | Cologne | 50931 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36912740 | Derived | Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3. |
| Label | URL |
|---|---|
| Publication on Eye | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | MITOMYCIN-C | Application of Mitomycin-C in trabeculectomy to reduce super-scarring. |
| FG001 | Ologen (Oculusgen) | The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MITOMYCIN-C | Application of Mitomycin-C in trabeculectomy to reduce super-scarring. |
| BG001 | Ologen (Oculusgen) | The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Intraocular Pressure Change | Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. | Posted | Mean | Standard Deviation | mm Hg | 360 days |
|
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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 | MITOMYCIN-C | Application of Mitomycin-C in trabeculectomy to reduce super-scarring. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders |
|
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Stat Methods and limited sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Dietlein, Ph. D., MD | Hospital of Universität Köln | +49 221 4785862 | 4300 | thomas.dietlein@uk-koeln.de |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| Mitomycin-C(MMC) and glaucoma filtering surgery | Drug | If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Complications | Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days. | Posted | Mean | Standard Deviation | percentage of participants | 360 days |
|
|
|
| Primary | Postoperative Intraocular Pressure Change | Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. | Posted | Mean | Standard Deviation | mm Hg | 180 days |
|
|
|
|
| Primary | Postoperative Intraocular Pressure Change | Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. | Posted | Mean | Standard Deviation | mm Hg | 90 days |
|
|
|
|
| Primary | Postoperative Intraocular Pressure Change | Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. | Posted | Mean | Standard Deviation | mm Hg | 30 days |
|
|
|
|
| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | Ologen (Oculusgen) | The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. | 0 | 10 | 0 | 10 |
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| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |