Efficacy and Safety of A0001 for Anterior Capsule Staining: Phase III Investigator-initiated Multicenter Clinical Trial
- Conditions
- Refractory cataract
- Registration Number
- JPRN-UMIN000028386
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) IOL implanted eye. 2) Has serious of digestive, circulatory, kidney, liver, or blood/coagulation complications 3) Had present and past uveitis or glaucoma 4) Those who fall under Grade 3 or Grade 4 in the classification of "Grading for Corneal Endothelial Damage (2014) "prescribed by the Japan Corneal Society. However, cases where it is difficult to measure the number of corneal endothelial cells by corneal clouding or the like can be incorporated. 5) Patient of Bullous keratopathy 6) Has a history of drug hypersensitivity reactions for mydriatic, antibacterial eyedrops or local anesthetic. 7) Has a history of drug or alcohol abuse 8) Had taken this clinical trial 9) Those who participated in other clinical trials or clinical studies within 30 days before consent acquisition and received medication, or those planning to participate in other trials during this trial 8) Is deemed unsuitable for this trial by PI or SI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Central evaluation of the efficacy of A0001 administered to anterior camber for visualization of the anterior capsule during cataract surgery.
- Secondary Outcome Measures
Name Time Method -Evaluation of degree of visualization and evaluation of ease of operation by surgeon. -Evaluation of the safety of A0001 based on data of adverse effects, side effects, ophthalmological examinations.