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临床试验/NCT04430647
NCT04430647已完成不适用

Phaco-UCP; Combined Phacoemulsification and Ultrasound Ciliary Plasty Versus Phacoemulsification Alone for Management of Coexisting Cataract and Open Angle Glaucoma

Ameera Gamal Abdelhameed1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
reduction in r the number of antiglaucoma medications.

研究概览

简要总结

This study was carried out to evaluate the safety and efficacy of combined phacoemulsification and Ultrasound ciliary plasty (Phaco-UCP) as a first-line surgical treatment of coexisting cataract and op

/en angle glaucoma compared to phacoemulsification alone. To our knowledge, this is the first report of results of combined Phaco-UCP

详细描述

the study involved 61 eyes of 61 patients with coexisting cataract and open angle glaucoma, 31 eyes were managed with Phaco-UCP and 30 eyes of age and sex matched patients were managed with phacoemulsification alone.

Patients were randomized for either combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) (the study group) or phacoemulsification alone (the control group). All surgeries were performed by one experienced surgeon (Y EZ).

Preoperative evaluation included manifest refraction, BCVA measurement, slit-lamp biomicroscopy, gonioscopy, indirect ophthalmoscopy, measurement of IOP with Goldmann applanation tonometry (average of 3 readings taken). Corneal diameter (White-to-white) and axial length measurement were done using IOL Master 500 (Carl Zeiss Meditec AG., Germany). Ultrasound pachymetry with Tomey SP-100 (Tomey Corp. Nagoya, Japan) and visual fields using Humphrey Field Analyzer (24-2, SITA, standard program Carl Zeiss Meditec AG., Germany) were also performed.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients diagnosed with POAG or pseudoexfoliation glaucoma with coexisting visually significant cataract that required phacoemulsification

排除标准

  • •patients with any other type of glaucoma, including narrow angle glaucoma, neovascular, uveitic or angle recession glaucoma, patients with advanced glaucoma characterized by advanced optic disc cupping or visual field damage, history of glaucoma or intraocular surgery and other ocular diseases that would affect safety or interfere with the procedure. We also excluded patients with incomplete follow-up or missing data

研究组 & 干预措施

Phaco alone

Active Comparator

A standard phacoemulsification was performed with 2.2 mm clear corneal incision, continuous curvilinear capsulorhexis, phacoemulsification and intrabagal implantation of foldable acrylic intraocular lens (AcrySof® IQ SN60WF monofocal; Alcon Laboratories Inc, Fort Worth, TX, USA) for all patients. Irrigation-aspiration was performed for at least 30 seconds to remove any viscoelastic from the anterior chamber. Reformation of the anterior chamber was done with balanced saline solution (BSS), followed by hydration of the corneal wound and side port.

干预措施: Phacoemulsification alone (Procedure)

phaco-UCP

Experimental

Under peribulbar anesthesia, UCP was performed first, followed by phacoemulsification. UCP was performed using the same technique described before [18]. For all treatments, 2nd generation probe was used (EyeOP1, Eye Tech care; France) with the same parameters; Operating frequency was 21 MHz. Number of sectors activated was 6. Acoustic power was 2.45 W; duration of each shot was 8s; and the time between shots was 20s. The probe diameter (11, 12 or 13 mm) was determined according to the eye's biometric readings. The coupling cone was centered on the eye and kept in place with low vacuum suction, followed by introduction of the treatment probe inside the cone, then activation of the transducers by constantly pressing the foot switch. Once UCP treatment was finished, phacoemulsification was commenced

干预措施: combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) (Procedure)

结局指标

主要结局

reduction in r the number of antiglaucoma medications.

时间窗: 18 months postoperative

reduction of the number of antiglaucoma medication or at least no increase in the number

reduction in intraocular pressure

时间窗: 18 months postoperative

Qualified Success was defined as an IOP reduction of at least 20 % from baseline value, with an IOP that is between 6 - 21 mm Hg, without the need for additional antiglaucoma medications or glaucoma surgery

次要结局

  • BCVA improvement(18 months postoperative)
  • intraoperative and postoperative complications.(intraoperative and 18 months postoperative)

研究者

发起方
Ameera Gamal Abdelhameed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ameera Gamal Abdelhameed

Lecturer of Ophthalmology

Mansoura University

研究点 (1)

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