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

Primary Open Angle Glaucoma Clinical Trial

— HFDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466526
• Other study ID #: 111-042-F
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Ko Mei-Lan, doctor
• Phone: +886-7265-4211
• Email: aaddch[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Surgery
• Glaucoma, Open-Angle
• Intraocular Pressure
• Primary Open Angle Glaucoma

Intervention

Procedure:
• High frequency deep sclerotomy (HFDS)
The surgery was performed using the abee® glaucoma tip of Oertli phacoemulsi?cation 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsin-Chu Branch	Hsinchu

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch	Local clinic

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of intraocular pressure (IOP) after HFDS treatments compared to preoperative IOP.	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.	Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.
Secondary	Change of visual acuity (VA) after HFDS treatments compared to preoperative VA.	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.	Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.