Design and Methodology of a Multi-Centre Clinical Trial of Low Dose Laser Cycloplasty for the Treatment of Malignant Glaucoma in China

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.

KEYWORDS:

• Malignant glaucoma
• low dose laser cycloplasty
• study design
• methodology
• multicentre trial

Acknowledgments

We wish to thank Jingwei Zheng and Kemi Feng for statistical consultation.

Disclosure statement

None from the Authors.

Submission statement

This submission has not been published anywhere previously and that it is not simultaneously being considered for any other publication.

Additional information

Funding

This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.