Study Of The Safety And Efficacy Of Intraoperative Subtenon Triamcinolone Acetonide Injection Versus Topical Prednisolone Acetate 1% In Reducing Postoprerative Inflammation After Phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
After cataract surgery, postoperative inflammation is commonly treated with corticosteroid eye drops such as prednisolone acetate 1%. However, frequent dosing may reduce patient compliance. This study compares topical corticosteroid drops with a single sub-Tenon's injection of triamcinolone acetonide in controlling postoperative inflammation after uncomplicated cataract surgery.
详细描述
Background: Postoperative ocular inflammation is a common physiological response following cataract surgery; however, excessive inflammation may compromise visual outcomes. Topical corticosteroids, particularly prednisolone acetate 1%, remain the standard treatment, but their use is limited by poor patient compliance and the need for frequent dosing. Sub-Tenon's corticosteroid injection offers a potential alternative with a prolonged anti-inflammatory effect.
Objective
To compare the safety and efficacy of a single sub-Tenon's injection of triamcinolone acetonide versus topical prednisolone acetate 1% in controlling postoperative inflammation after uncomplicated cataract surgery.
Methods: This prospective, randomized, interventional comparative study included 72 patients undergoing phacoemulsification surgery. Participants were randomly assigned into two groups: Group 1 received topical prednisolone acetate 1% according to a tapering regimen, while Group 2 received a single sub-Tenon's injection of triamcinolone acetonide (40 mg/mL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 52 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for senile cataract surgery meeting the following conditions:
- •Best-corrected visual acuity less than or equal to 0.
- •Nuclear sclerosis grades NC1, NC2, NC3, or NC4 according to LOCS III, regardless of the grade of cortical or posterior subcapsular cataract.
- •Age 50 years and older.
排除标准
- •Patients with non-age-related cataracts (congenital, infantile, or drug-induced).
- •Patients with a history of previous intraocular surgery. Patients with any form of glaucoma. Patients with pseudoexfoliation syndrome. Patients with diabetes mellitus. Patients with uveitis. Patients scheduled for concurrent intraocular surgery at the time of cataract extraction (e.g., trabeculectomy or vitrectomy).
- •Patients using long-term topical ocular medications. Patients with only one functional eye. Patients with poor pupil dilation, defined as a pupil diameter of 5.5 mm or less, those requiring iris dilators, or those who experienced iris trauma during surgery.
- •Effective phacoemulsification time (EPT) exceeding 2 minutes. Patients who were non-compliant with follow-up visits. Patients who developed postoperative complications unrelated to the study treatment (such as endophthalmitis or intraocular lens dislocation).
研究组 & 干预措施
Intraoperative Subtenon Triamcinolone Acetonide
干预措施: Triamcinolone acetonide injection (Drug)
Topical Prednisolone Acetate 1%
干预措施: prednisolone acetate 1% (Drug)
研究者
Sameh Issa
Professor
Damascus University