Cataract Surgery Clinical Trial
Official title:
Intracameral Antibiotic Safety Study
NCT number | NCT02590523 |
Other study ID # | 3 |
Secondary ID | |
Status | Suspended |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | January 2023 |
Est. completion date | January 2024 |
Verified date | April 2022 |
Source | Panhandle Eye Group, LLP |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to determine the safety (but not efficacy in preventing infection) of sterile-packaged and pre-loaded injectable solutions of both vancomycin and moxifloxacin at certain dosages and concentrations as prepared by a compounding pharmacy when used intracamerally at the time of cataract surgery.
Status | Suspended |
Enrollment | 500 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 100 Years |
Eligibility | Inclusion Criteria: - Diagnosis of visually significant cataract - Appropriate candidate for cataract surgery Exclusion Criteria: - Not willing to undergo an investigational treatment or are unable to cooperate well enough to safely perform the procedure under the protocol guidelines - Has known allergies to the pre-/intra-/post-operative medications or preservatives in the medications will also be excluded - Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason - Has a known history of a condition which causes an immuno-compromised host state |
Country | Name | City | State |
---|---|---|---|
United States | Rush Eye | Amarillo | Texas |
Lead Sponsor | Collaborator |
---|---|
Panhandle Eye Group, LLP |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Endothelial cell count measured by specular microscopy | specular microscopy | 3 months | |
Other | Rate of postoperative complication | 3 months | ||
Primary | Occurrence of adverse event | 3 months | ||
Secondary | Postoperative visual acuity measured by best spectacle corrected | best spectacle corrected | 3 months |
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