Status:
COMPLETED
A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery
Lead Sponsor:
Ocumension Therapeutics (Shanghai) Co., Ltd
Conditions:
Inflammation
Cataract
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts.
Detailed Description
To evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts in real-world clinical settings, medical history and follow-up data from 113 subjects of Dexycu group ...
Eligibility Criteria
Inclusion
- Subjects must be able to understand and sign the informed consent form and be able to follow the study procedures.
- Male or female subjects over 40 years of age who are scheduled to undergo cataract phacoemulsification surgery combined with intraocular lens implantation.
Exclusion
- Known hypersensitivity to dexamethasone or any component of the Dexycu.
- History of intraocular inflammation of any cause in either eye, presence of corneal abnormalities or malnutrition.
- Have high intraocular pressure, with an IOP(intraocular pressure) of \> 21 mmHg in the test eye at screening, regardless of whether receiving anti-glaucoma monotherapy therapy.
- Posterior capsule rupture or lens dislocation, anterior vitreal membrane rupture, vitreous prolapse and intraoperative floppy iris syndrome during cataract surgery.
- Other conditions that the investigator considers inappropriate to participate the study.
Key Trial Info
Start Date :
October 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT06497699
Start Date
October 28 2021
End Date
December 14 2023
Last Update
September 3 2025
Active Locations (2)
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1
Hainan Traditional Chinese Medicine Hospital
Haikou, Hainan, China
2
Boao Super Hospital
Bo'ao, China