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This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts.
To evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts in real-world clinical settings, medical history and follow-up data from 113 subjects of Dexycu group and 150 subjects of external control group will be prospectively collected in Hainan, China. Additionally, questionnaires will be collected from surgeons on 30 cases to evaluate the difficulty, duration and safety of the Dexycu injector.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Single injection of DEXYCU in the treatment eye after cataract surgery. |
|
| Control Group | No Intervention | The clinical routine treatment after cataract surgery was adopted without intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexycu | Drug | single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cell Clearing Rate | The primary outcome is to compare the ratio of subjects with anterior chamber cell grade 0 at day 8 after cataract surgery of both Dexycu group and external control group. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0). | DAY 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhixun Li | Ocumension Therapeutics (Shanghai) Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan Traditional Chinese Medicine Hospital | Haikou | Hainan | China | |||
| Boao Super Hospital |
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113 recruited to the study group treat with DEXYCU postsurgerically. 150 recruited to control group which observation study was conducted.
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | The clinical routine treatment after cataract surgery was adopted without intervention |
| FG001 | Study Group | Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | The clinical routine treatment after cataract surgery was adopted without intervention |
| BG001 | Study Group | Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Anterior Chamber Cell Clearing Rate | The primary outcome is to compare the ratio of subjects with anterior chamber cell grade 0 at day 8 after cataract surgery of both Dexycu group and external control group. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0). | 1 control group participant loss to follow up before reaching DAY 8. | Posted | Count of Participants | Participants | DAY 8 |
|
Through study completion, an average of 90 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 | Control Group | The clinical routine treatment after cataract surgery was adopted without intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal endothelial cell loss | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Ocumension Therapeutics (Shanghai) Co., Ltd | 2289 3653 | 3653 | clinicalop@ocumension.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2022 | Jul 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Study group:Dexycu interventional group
External control group;without intervention
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| Bo'ao |
| China |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Study Group | Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone |
|
|
| 0 |
| 150 |
| 5 |
| 150 |
| 14 |
| 150 |
| EG001 | Study Group | Single injection of DEXYCU in the treatment eye after cataract surgery. Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone | 1 | 113 | 1 | 113 | 15 | 113 |
| Diplopia | Eye disorders | Systematic Assessment |
|
| Macular Oedema | Eye disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |