Adverse Events Clinical Trial
— Clinical PASOfficial title:
ReSure Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery
Verified date | December 2016 |
Source | Ocular Therapeutix, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.
Status | Completed |
Enrollment | 626 |
Est. completion date | April 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 22 Years and older |
Eligibility |
Inclusion Criteria: - Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement Exclusion Criteria: - ReSure Sealant is not applied to the operative eye |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ocular Therapeutix, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anterior chamber cells greater than level 1+ persisting at Visit 2 (= Day 20) | Post operative days 20 to 40 | Yes | |
Primary | Hypotony (= 5 mmHg) | Post operative days 20 to 40 | Yes | |
Primary | Ocular discomfort | Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8 | Post operative days 20 to 40 | Yes |
Primary | Surgical reintervention | Surgical reintervention for management of a wound leak - Yes or No | Post operative days 20 to 40 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05390125 -
Effectiveness of a Proficiency-based Progression Communication Training Programme
|
||
Completed |
NCT04012320 -
Efficacy and Safety on the Use of Bisphosphonates in Paediatrics
|
||
Completed |
NCT02268331 -
Comparison of Active vs. Passive Surveillance to Collect Adverse Events
|
N/A | |
Completed |
NCT00244673 -
Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination
|
Phase 4 | |
Recruiting |
NCT05038527 -
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery
|
N/A | |
Completed |
NCT01291667 -
Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE
|
Phase 3 | |
Completed |
NCT00681395 -
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
|
Phase 1 | |
Completed |
NCT05359666 -
Retrospective Independent Safety Review of Closed Irrisept Study
|
N/A | |
Recruiting |
NCT05311566 -
PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer
|
Phase 2 | |
Recruiting |
NCT05310344 -
Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer
|
Phase 2 | |
Recruiting |
NCT05311579 -
Niraparib Plus Anlotinib for Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT05815615 -
Plasmapheresis: a Multi-modal Approach
|
N/A | |
Completed |
NCT02130570 -
Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
|
N/A | |
Recruiting |
NCT05804188 -
CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
|
||
Not yet recruiting |
NCT06117176 -
Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III
|
||
Recruiting |
NCT02725073 -
Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma
|
Phase 2 | |
Completed |
NCT02928705 -
Quality of Telemedically Guided Prehospital Analgesia
|
N/A | |
Terminated |
NCT02011607 -
Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia
|
||
Withdrawn |
NCT01128127 -
Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
|
N/A | |
Recruiting |
NCT05709392 -
Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
|
N/A |