Effect of Trypan Blue on Corneal Endothelial Cell Count During Phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Corneal Endothelial Cell Count
研究概览
简要总结
This randomized controlled trial evaluated the effect of trypan blue on corneal endothelial cell count in patients undergoing phacoemulsification for age-related cataract. Sixty participants were randomly assigned to undergo phacoemulsification either with trypan blue-assisted anterior capsule staining or without trypan blue. The primary objective was to compare postoperative corneal endothelial cell count between the two groups using specular microscopy to determine whether trypan blue has an effect on corneal endothelial cell loss during cataract surgery.
详细描述
Age-related cataract is one of the leading causes of reversible visual impairment worldwide. Trypan blue is commonly used during phacoemulsification to stain the anterior lens capsule, particularly in mature or dense cataracts, to facilitate continuous curvilinear capsulorhexis. Although trypan blue improves intraoperative visualization, concerns remain regarding its potential effect on the corneal endothelium.
This single-center, parallel-group, randomized controlled trial was conducted at the Department of Ophthalmology, Hayatabad Medical Complex, Peshawar, Pakistan. Sixty patients aged 45 to 75 years with age-related cataract scheduled for phacoemulsification were randomly allocated in a 1:1 ratio to undergo phacoemulsification either with trypan blue-assisted anterior capsule staining or without trypan blue. All procedures were performed using a standardized surgical technique by the same surgical team.
The primary outcome was postoperative corneal endothelial cell count measured by specular microscopy. The study compared postoperative endothelial cell counts and endothelial cell loss between the two treatment groups to evaluate the effect of trypan blue on corneal endothelial safety during phacoemulsification.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 45 to 75 years.
- •Diagnosed with age-related cataract.
- •Scheduled to undergo phacoemulsification with posterior chamber intraocular lens implantation.
- •Able and willing to provide written informed consent.
排除标准
- •Diabetes mellitus.
- •Glaucoma.
- •Previous ocular surgery.
- •Corneal opacity.
- •Pre-existing corneal endothelial disease.
- •Traumatic cataract.
- •Complicated cataract.
- •Any other ocular pathology that could affect corneal endothelial cell count or interfere with study outcomes.
研究组 & 干预措施
Trypan Blue Group
Participants underwent standard phacoemulsification with intracameral trypan blue staining of the anterior lens capsule before capsulorhexis, followed by intraocular lens implantation using a standardized surgical technique
干预措施: Phacoemulcification (Procedure)
Control Group
Participants underwent standard phacoemulsification without trypan blue staining of the anterior lens capsule, followed by intraocular lens implantation using the same standardized surgical technique.
干预措施: Phacoemulcification (Procedure)
Trypan Blue Group
Participants underwent standard phacoemulsification with intracameral trypan blue staining of the anterior lens capsule before capsulorhexis, followed by intraocular lens implantation using a standardized surgical technique
干预措施: Trypan Blue (Drug)
结局指标
主要结局
Postoperative Corneal Endothelial Cell Count
时间窗: At 4 weeks after surgery
Corneal endothelial cell density was measured by specular microscopy and reported as cells/mm². The mean postoperative endothelial cell count was compared between the trypan blue group and the control group.
次要结局
未报告次要终点
研究者
Naz Ullah
Dr.
Hayat Abad Medical Complex, Peshawar