Cataract, Glaucoma
Conditions
Keywords
Glaucoma, Collagen matrix, OculusGen, Phacotrabeculectomy, anti scarring, tissue engineering, ologen, Aeon Astron
Brief summary
1. . Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of Intraocular Pressure, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. . Study Design: The study is designed as a historical controlled study. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. The allocation of subjects is non-randomized, and there is a single group for assignment. 3. . Follow-Up: This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90 and 180 day visits. The further follow-up of subject after trial is continually tracked by the investigator.
Detailed description
ologen collagen matrix is applied for the phacotrabec surgery.
Interventions
OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
Sponsors
Pro Top & Mediking Company Limited
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject inclusion criteria: 1. Age 18 years or over. 2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy. 3. Visually significant cataract with visual acuity of less than or equal to 6/12. 4. Subject able and willing to cooperate with investigation plan. 5. Subject willing to sign informed consent form. Subject
Exclusion criteria
1. Known allergic reaction to collagen. 2. Subject is on Warfarin and discontinuation is not recommended. 3. Subject with normal tension glaucoma or aphakic glaucoma. 4. Subject with corneal disease. 5. Participation in an investigational study during the 30 days proceeding phacotrabeculectomy. 6. Ocular infection within 14 days prior to phacotrabeculectomy. 7. Pregnant or breast-feeding women. 8. Monocular subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative and Postoperative Intraocular Pressure | baseline and 90 days | The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Complications or Adverse Events. | 180 day | Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OculusGen Collagen Matrix OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | OculusGen Collagen Matrix |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 4 |
| Region of Enrollment India | 10 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Preoperative and Postoperative Intraocular Pressure
The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.
Time frame: baseline and 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OculusGen Collagen Matrix | Preoperative and Postoperative Intraocular Pressure | Preoperative intraocular pressure | 20.1 mm Hg | Standard Deviation 8.02 |
| OculusGen Collagen Matrix | Preoperative and Postoperative Intraocular Pressure | Postoperative intraocular pressure | 9 mm Hg | Standard Deviation 3.32 |
Comparison: Null hypothesis: the postoperative intraocular pressure at 90 days equals the preoperative intraocular pressure at baseline.p-value: 0.01t-test, 2 sided
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.
Time frame: 180 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OculusGen Collagen Matrix | Number of Participants With Any Complications or Adverse Events. | 0 participants |