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

Not Applicable

Recruiting

• Conditions: Glaucoma Surgery; Primary Open Angle Glaucoma; Intraocular Pressure
• Interventions: Procedure: High frequency deep sclerotomy (HFDS)

• Registration Number: NCT05466526
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Brief 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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-17
• Study First Posted: 2022-07-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-13
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The participants who received HFDS	High frequency deep sclerotomy (HFDS)	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.

Primary Outcome Measures

Name	Time	Method
Change of intraocular pressure (IOP) after HFDS treatments compared to preoperative IOP.	Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.	The postoperative IOP will be measured in every follow-up visit for 6 months after the operation. If the IOP of the participants is lower than that before the operation, and there is no tendency to increase within six months as well as no additional complications occur, the benefits of the primary outcome will be achieved.

Secondary Outcome Measures

Name	Time	Method
Change of visual acuity (VA) after HFDS treatments compared to preoperative VA.	Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.	The postoperative visual acuity(VA) will be measured in every follow-up visit for 6 months after the operation. If the VA of the participants is getting better than that before the operation, and there is no tendency to worse within six months as well as no additional complications occur, the benefits of the secondary outcome will be achieved.

Trial Locations

Locations (1)

National Taiwan University Hospital Hsin-Chu Branch; 🇨🇳 Hsinchu, Taiwan