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

National Taiwan University Hospital Hsin-Chu Branch

Status: Enrolling

Conditions: Primary Open Angle Glaucoma; Intraocular Pressure; Glaucoma Surgery

Treatments: Procedure: High frequency deep sclerotomy (HFDS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05466526

111-042-F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic open angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment.

Exclusion criteria

• Patients with close-angle, congenital, traumatic, neovascular, and uveitic glaucoma, patients with prior penetrating and nonpenetrating glaucoma surgeries or laser therapy, and eyes with corneal opacity precluding visualization of the angle.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

The participants who received HFDS

Experimental group

Description:

All participants in the arm were suffering from primary open-angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment.

Treatment:

Procedure: High frequency deep sclerotomy (HFDS)