Refractory cataract
Conditions
Interventions
Brilliant Blue G250
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: There are indications for cataract surgery for one eye or both eyes, and cataract with severe cortical cataract, mature cataract, hyperzagmus cataract, cataract with corneal opacity, cataract with vitreous opacity, etc. Cataract in which it is difficult to see the anterior capsule of the lens in normal cataract surgery.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central evaluation of the efficacy of A0001 administered to anterior camber for visualization of the anterior capsule during cataract surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| -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. | — |
Countries
Japan
Contacts
Public ContactMakiko Uchiyama
Kyushu University Hospital Center for Clinical and Translational Research
Outcome results
None listed