当前位置: X-MOL 学术Ophthalmic Epidemiol. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Design and Methodology of a Multi-Centre Clinical Trial of Low Dose Laser Cycloplasty for the Treatment of Malignant Glaucoma in China
Ophthalmic Epidemiology ( IF 1.7 ) Pub Date : 2021-08-25 , DOI: 10.1080/09286586.2021.1966809
Haishuang Lin 1 , Jibing Wang 2 , Sujie Fan 3 , Zuohong Wu 4 , Xiaoping Xu 5 , Qinhua Cai 6 , Lijun Zhao 7 , Sumian Cheng 8 , Shaodan Zhang 1, 9 , Yuanbo Liang 1, 9 ,
Affiliation  

ABSTRACT

Purpose

To summarize the design and methodology of a trial designed to evaluate the efficacy and safety of low dose laser cycloplasty (LCP) in treating malignant glaucoma.

Methods

Prospective, multicentre, non-controlled clinical trial. Subjects were recruited from eight ophthalmic centers in China. The target sample size was 34. Patients aged >18 years with a clinical diagnosis of malignant glaucoma inadequately controlled on medical therapy or malignant glaucoma recurrence after topical cycloplegics withdrawal were enrolled. All patients underwent LCP under retrobulbar anesthesia or sub-Tenon anesthesia. LCP is a treatment adopting few laser points (1100–2000 mW energy, 2000 milliseconds duration) that cauterizes and remodels the ciliary body over two clock hour-positions, which may relieve the ciliary ring block. Follow-up is planned for a period of 12 months. The primary outcome is the resolution of malignant glaucoma which is defined as central anterior chamber deepening after LCP.

Conclusion

The Malignant Glaucoma Treatment trial (MGTT) will be the first prospective trial providing evidence of a treatment for malignant glaucoma. It intends to provide clinicians an optional, easy and convenient treatment for malignant glaucoma patients. Detailed morphological and biometric information collected during the study period will also help provide experience for the outcomes of malignant glaucoma.

Trial registration number

ChiCTR1800017960.

更新日期:2021-08-25
down
wechat
bug