Phase 4
N=263
A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery
Inflammation · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT06497699 ↗Enrolled (actual)
263
Serious AEs
2.3%
Results posted
Sep 2025
Primary outcome: Primary: Anterior Chamber Cell Clearing Rate — 119; 95 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexycu (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Ocumension Therapeutics (Shanghai) Co., Ltd
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anterior Chamber Cell Clearing Rate |
119; 95 | — |
Summary
This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06497699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.