Cataract
Conditions
Interventions
Test Group:Treated with Catacure-I
Sponsors
Cataract Clinical Center, Eye Hospital WMU
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Subject aged between 55 and 85 years of age (inclusive) at the time of consent 2. Subject diagnosed with Age-related cataract 3. Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator 4. Best Corrected Visual Acuity (BCVA) of 0.3 LogMAR or worse due to cataract only 5. Intraocular pressure=21mmHg 6. Subjects whose Investigator and medical records have reviewed the medical health history records do not contraindicate participation in the study 7. Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator - including being able to sit upright for at least 20 mins (duration of the treatment) 8. Subject who is judged suitable for the study after ophthalmic examination carried out by the Investigator 9. No other eye diseases and systemic organic disorders significantly affect vision
Exclusion criteria
Exclusion criteria: 1. The clinical diagnosis of eye diseases that affect vision other than cataracts, including glaucoma, fundus diseases, amblyopia, optic neuropathy, etc., may affect the treatment, or affect the ability of the subject to be evaluated after treatment. 2. Patients with severe diabetes, hypertension, and other general conditions under control (HbA1C>9% or fasting blood glucose>11.1 mmol/L; systolic blood pressure>160 mmHg or diastolic blood pressure>95 mmHg). 3. Patients who need long-term use of hormone drugs. 4. Subjects with intraocular lens (IOL) implant in either eye 5. Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period 6. Subject with shallow anterior chamber 7. Subject who have had a fluorescence angiogram or any use of fluorescein within the last 3 days 8. Subject presenting eye infection or eye damage in either eye 9. Any condition which could interfere with the subject's ability to comply with the study including participation in all study assessments and visits. 10. Subject who had undergone a treatment using photodynamic drugs within the last 30 days. (Including but not limited to methylene blue, toluidine blue, Visudyne?, Foscan, Photofrin or 5-aminolevulinic acid/ALA) 11. Subject diagnosed with any other health condition which, in the opinion of the Investigator, would pose a safety risk to the subject by participating in the study, or may interfere with or jeopardise the study evaluation, procedures or completion 12. Subject currently receiving treatment in another investigational study or has completed another investigational study within the last 30 days 13. Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalised by the court or official order, or in a dependency relationship with the sponsor, testing centre or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Best Corrected Visual Acuity (BCVA);Macular safety;optic disk safety;Intraocular pressure;Ocular Fundus safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective scattering index;Change in Cataract Severity; | — |
Countries
China
Contacts
Public ContactDr. Ayong Yu
Eye Hospital WMU
Outcome results
None listed