Clinical trial NCT06497699: A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery
Official title: A Real-world Study to Evaluate the Efficacy and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
Cataract
Keywords: Cataract Surgery
Postoperative Inflammation
Lead sponsor: Ocumension Therapeutics (Suzhou) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 263
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study group:Dexycu interventional group

External control group;without intervention
Primary purpose: TREATMENT

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 and 150 subjects of external control group will be prospectively collected in Hainan, China. Additionally, questionnaires will be collected from surgeons on 30 cases to evaluate the difficulty, duration and safety of the Dexycu injector.

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.

Primary outcomes:
measure: Anterior chamber cell clearing rate
timeFrame: DAY 8
Secondary outcomes:
measure: Anterior chamber cell clearing rates
timeFrame: DAY 1 & 30
measure: Anterior chamber flare clearing rates
timeFrame: DAY 1 & 8
measure: Mean anterior chamber cell score
timeFrame: DAY 1 & 8 & 30
measure: Mean anterior chamber flare score
timeFrame: DAY 1 & 8 & 30
measure: Change in central macular thickness
timeFrame: DAY 1 & 8
measure: Change in vision
timeFrame: DAY 1 & 8 & 30
measure: Evaluate the ease of use of the Dexycu ejector
timeFrame: DAY 0
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Traditional Chinese Medicine Hospital
state: Hainan
city: Bo'ao
country: China
facility: Boao Super Hospital
Study officials:
affiliation: Ocumension Therapeutics (Shanghai) Co., Ltd
name: Zhixun Li
role: STUDY_DIRECTOR
References: