NCT05466526

Microinvasive Glaucoma Surgery -The Lowering Effect of Intraocular Pressure on Glaucoma Patients With High Frequency Deep Sclerotomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Highlights the high-frequency deep sclerotomy (HFDS) as a promising ab-interno surgery in primary open-angle glaucoma (POAG) patients and evaluates the efficacy and safety of the procedure.

Detailed description

\[Materials and Methods \] This is a single-centre, prospective, non-blinded, interventional trials designed to evaluate the therapeutic effect and safety of HFDS in POAG patients. A total of 30 subjects were recruited, all of whom were outpatients of the ophthalmology department of attending physician MeiLan Ko in the National Taiwan University Hospital Hsin-Chu Branch. The 20 subjects were all diagnosed with POAG. The surgery was performed in the surgery room of the National Taiwan University Hospital Hsin-Chu Branch. The surgery was performed using the abee® glaucoma tip of Oertli phacoemulsification machine (Cata-rhex3, Switzerland) and goniolens. During the procedure, nasal six pockets penetrating 1mm deep into the trabecular meshwork and Schlemm's canal were formed to promote aqueous humor outflow. \[Postoperative follow-up and evaluation\] The postoperative IOP and visual acuity (VA) were measured in every follow-up visit for 6 months. Postoperatively, Cravit/Lotemax drops were given to prevent inflammation and infections; besides, Pilocarpine 2% eye drops were provided to reduce IOP for postoperative medication. \[Data Statistics and Analysis\] Statistical analysis was done by IBMSPSS v21.0 statistical software (IBM Corporation, New York, USA). Data analysis was done by chi square (χ2) test, paired samples T-test and repeated ANOVA measurements with Bonferroni post hoc analysis. The results are considered statistically significant with a P value \<0.05.

Conditions

• Primary Open Angle Glaucoma
• Intraocular Pressure
• Glaucoma Surgery

Interventions

Type	Name	Description
PROCEDURE	High frequency deep sclerotomy (HFDS)	The surgery was performed using the abee® glaucoma tip of Oertli phacoemulsification machine (Cata-rhex3, Switzerland) and goniolens. During the procedures, nasal six pockets penetrating 1mm deep from the trabecular meshwork to Schlemm's canal will be formed to promote the aqueous humor outflow.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-07-20
• Last updated: 2022-12-13

Locations

1 site across 1 country: Taiwan