A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery
NCT Number: NCT06497699
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Inflammation|Cataract
Interventions: DRUG: Dexycu
Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 263
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-10-28
Completion Date: 2023-12-14
Locations: Hainan Traditional Chinese Medicine Hospital, Haikou, Hainan, China|Boao Super Hospital, Bo'ao, China

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

Primary Outcome Measures: Anterior chamber cell clearing rate, The primary outcome is to compare the ratio of subjects with anterior chamber cell grade 0 at day 8 after cataract surgery of both Dexycu group and external control group.

The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0)., DAY 8
Secondary Outcome Measures: Anterior chamber cell clearing rates, Compare the percentage of subjects with anterior chamber clearing grade 0 at Day 1 and 30 after cataract surgery of both Dexycu group and external control group.

The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0)., DAY 1 & 30|Anterior chamber flare clearing rates, Compare the percentage of subjects with anterior chamber flare grade 0 at Day 1 and 8 after cataract surgery of both Dexycu group and external control group.

The slit lamp examination for anterior chamber flare (ACF) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent), grade 1 (trace), grade 2 (mild intensity), grade 3 (moderate intensity), or grade 4 (strong intensity). Anterior chamber flare clearing occurs when all the ACC are absent (grade 0)., DAY 1 & 8|Mean anterior chamber cell score, Compare the mean score of anterior chamber cell at Day 1 , 8 and 30 of the Dexycu group and external control group., DAY 1 & 8 & 30|Mean anterior chamber flare score, Compare the mean score of anterior chamber flare at Day 1, 8 and 30 of the Dexycu group and external control group., DAY 1 & 8 & 30|Change in central macular thickness, Compare the change in central macula thickness at Day 1 and 8 of the Dexycu group and external control group., DAY 1 & 8|Change in vision, Use standard logarithmic visual acuity chart to measure and compare the change in vision of the Dexycu group and external control group, before and after cataract surgery., DAY 1 & 8 & 30|Evaluate the ease of use of the Dexycu ejector, After the cataract surgery, surgeons are asked to fill in a questionaire designed to collect subjective assessment on the experience of using the drug ejector. 30 questionaires in total were collected., DAY 0