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Prospective Randomized Controlled Study on the Application of a Novel Antibacterial Hydrogel Dexamethasone Sustained-Release Agent Following Intraocular Surgery

Prospective Randomized Controlled Study on the Application of a Novel Antibacterial Hydrogel Dexamethasone Sustained-Release Agent Following Intraocular Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122318
Enrollment
Unknown
Registered
2026-04-12
Start date
2026-01-12
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

None

Interventions

Dexamethasone eye drops standard treatment group:Dexamethasone eye drops
Antibacterial hydrogel dexamethasone sustained-release injection treatment group via subconjunctival administration:Antibacterial hydrogel dexamethasone sustained-release injection treatment

Sponsors

Tongji Hospital of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients aged 30 years or older, regardless of gender; 2.Diagnosis of cataract in the affected eye and scheduled for phacoemulsification with intraocular lens implantation; 3.Cataract graded as 3 or 4 according to the Lens Opacities Classification System III (LOCS III); 4.Corneal endothelial cell count greater than 1200 cells/mm^2.

Exclusion criteria

Exclusion criteria: 1.Patients under the age of 30; 2.Lens opacity graded as 0-2 or grade 5 nuclear according to the Lens Opacities Classification System III (LOCS III); 3.Corneal endothelial cell count less than 1200 cells/mm^2; 4.A history of unexplained recurrent anterior/posterior segment inflammation in the operative eye; 5.A history of ocular trauma in the operative eye within the previous year; 6.The presence of any ocular condition that may affect treatment efficacy or evaluation, such as ocular infection, corneal disease, glaucoma, ocular hypertension, severe dry eye, uveitis, retinal detachment, optic neuropathy, amblyopia, or cataract surgery combined with other types of surgery (e.g.corneal transplantation, vitrectomy, glaucoma surgery, etc.); 7.The surgical eye has a history of congenital structural abnormalities; 8.The surgical eye has undergone eye surgery within the past year; 9.The surgical eye has specific ocular conditions that may affect the surgery, such as restricted pupil dilation; 10.Intraoperative or postoperative complications exist in the surgical eye, such as posterior capsule rupture, hyphema, lens nucleus dislocation, retained lens fragments, or vitreous prolapse; 11.The patient has systemic diseases that may affect the treatment outcome or evaluation, such as systemic autoimmune diseases; 12.Ocular medications other than antibiotics eye drops/artificial tears, such as corticosteroid eye drops, nonsteroidal anti-inflammatory drugs, antihistamines, etc., were used within 14 days prior to the study; 13.Known or suspected allergies to corticosteroids or preservatives; 14.Patients unable to attend follow-up visits one month after surgery; 15.Pregnant or breastfeeding women, or those with a fertility plan during the study period; 16.Individuals with cognitive impairment or psychiatric disorders who are unable to understand or comply with the study protocol; 17.Individuals with systemic conditions deemed inappropriate for participation in the clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Macular edema;Anterior chamber flicker;

Secondary

MeasureTime frame
Best corrected visual acuity;Intraocular pressure;Eye redness;Eye pain;Conjunctival hemorrhage;Corneal epithelial staining score;Corneal thickness;Vital signs;Laboratory examination;Surgical complications;

Countries

China

Contacts

Public ContactBing Li

Tongji Hospital of Tongji University

bing.li@tongji.edu.cn+86 21 6611 1041

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026