Amniotic Membrane for External Dacryocystorhinostomy and Comparison of Success Rate With Conventional Surgery for Patients With Nasolacrimal Duct Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Functional success rate
研究概览
简要总结
This study aims to compare the success rate of external dacryocystorhinostomy with and without amniotic membranes in patients with nasolacrimal duct obstruction.
详细描述
Naso-lacrimal duct obstruction (NLDO) causes epiphora, recurrent dacryocystitis, and skin fistulas. Its incidence increases with age. Dacryocystorhinostomy (DCR) is considered the standard treatment for NLDO. Authors describe similar success rates between external or endoscopic approaches. The former uses a skin approach, through which an osteotomy is made, allowing access to the lacrimal sac and subsequently to the middle meatus of the nasal cavity. On the other hand, endoscopic surgery uses an endonasal route to create a fistula towards the lacrimal sac, with the benefit of not generating visible scars in patients. The success of both surgeries depends on creating a wide osteotomy and the preservation of the mucosa around it, reducing the risk of scarring and stenosis of the ostium formed.
Some authors suggest that limiting the inflammatory process localized to the osteotomy may improve the surgical success rate. The use of mitomycin C (MMC) has been reported, with limited results due to variability in the concentration and methods of drug used.
Amniotic membrane (AM) has been used in ophthalmology, such as in pterygium surgery, chemical trauma, and inflammatory diseases of the ocular surface. In these contexts, AM limits the inflammatory response, promotes re-epithelialization, and reduces fibrosis. AM epithelial cells do not express HLA-A, B, C, or DR antigens on their surface, and therefore do not present a risk of rejection by the immune system.
This study aims to compare the success rate of external DCR with and without amniotic membranes in patients with NLDO.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors were masked to treatment allocation. The surgeon was not masked because of the nature of the surgical intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Diagnosis of Nasolacrimal Duct Obstruction or Score ≥ 2 on the Munk Scale
- •Patients able to undergo general anesthesia
- •Patients able to keep follow-up
- •Patients willing to participate in the study and signed informed consent
排除标准
- •Patients with ocular surface diseases that affect surgical outcomes, such as blepharitis, lacrimal punctum epithelization, kissing punctae, facial nerve palsy, allergic conjunctivitis, etc
- •Patients with eyelid malpositions
- •Patients diagnosed with systemic inflammatory diseases, such as granulomatosis with polyangiitis, sarcoidosis, etc
- •Previous history of facial trauma with nasal bone fractures
- •Pregnancy and lactation
研究组 & 干预措施
Conventional dacryocystorhinostomy
Patients undergoing conventional dacryocystorhinostomy using external approach.
干预措施: Conventional dacryocystorhinostomy (Procedure)
Dacryocystorhinostomy using amniotic membrane
Patients undergoing conventional dacryocystorhinostomy using external approach and adding amniotic membrane over the osteotomy, fixed with sutures.
干预措施: Dacryocystorhinostomy and amniotic membrane (Procedure)
结局指标
主要结局
Functional success rate
时间窗: 6 months after surgery
Clinical evidence of epiphora
次要结局
- Osteotomy aspect(6 months after surgery)
- Nasolacrimal duct permeability(6 months after surgery)
- Visual acuity(Pre treatment)
- Surgical Complications(At the date of surgery)