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To evaluate the protection of corneal endothelial function after phacoemulsification of hard (LOCS>=5) cataract with nicotinamide injection compared with normal infusion liquid phase: a double-blind, randomized controlled clinical trial

Protective effect of niacinamide on corneal endothelial injury induced by cataract phacoemulsification

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078118
Enrollment
Unknown
Registered
2023-11-29
Start date
2023-12-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cataract

Interventions

Control Group:Conventional cataract phacoemulsification was performed using normal perfusion BSS
Experimental group:Nicotinamide injection was added into the perfusion solution to perform conventional cataract phacoemulsification

Sponsors

Qingdao Eye Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosis of cataract and cataract phacoemulsification surgery, aged >= 60 years; 2. Cataract grade: according to the international standard (LOCS III) divided into grade 5 or above,

Exclusion criteria

Exclusion criteria: 1. Subjects with abnormal corneal endothelium or a history of corneal disease or surgery, such as Fuchs endothelial dystrophy, corneal endothelium less than 1500 /mm2, after penetrating corneal transplantation, etc. 2. Ocular trauma and surgical history; 3. Other ocular disease (inflammatory diseases such as uveitis, glaucoma, and severe retinopathy, etc) 4. Known allergy to experimental drugs.

Design outcomes

Primary

MeasureTime frame
Corneal endothelial cell loss rate;

Secondary

MeasureTime frame
corneal thickness;visual acuity;intraocular pressure;Anterior chamber flare;Anterior chamber cell;Sensitivity parameters of corneal endothelial cell distortion (Xin value);anterior chamber depth;lens thickness;Cataract nuclear hardness;

Countries

China

Contacts

Public ContactXiaoming Wu

Qingdao Eye Hospital of Shandong First Medical University

wuxiaominglmm@126.com+86 134 7532 6608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026