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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-28

Study Completion Date

2023-12-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Inflammation Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Study group:Dexycu interventional group

External control group;without intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

Single injection of DEXYCU in the treatment eye after cataract surgery.

Group Type EXPERIMENTAL

Dexycu

Intervention Type DRUG

single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone

Control Group

The clinical routine treatment after cataract surgery was adopted without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexycu

single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No