A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery

Ocumension Therapeutics (Shanghai) Co., Ltd

Status and phase

Completed

Phase 4

Conditions

Inflammation

Cataract

Treatments

Drug: Dexycu

Study type

Interventional

Funder types

Industry

Identifiers

NCT06497699

OT-502-002

Details and patient eligibility

About

This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts.

Full 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.

Enrollment

263 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.