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

NCT05466526 | Unknown

• 1 other identifier: 111-042-F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Intraocular Pressure; Glaucoma Surgery

Keywords

Primary Open Angle Glaucoma; High frequency deep sclerotomy; Abee glaucoma tip of Oertli

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

The participants who received HFDS

EXPERIMENTAL

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.

Procedure: High frequency deep sclerotomy (HFDS)

Interventions

High frequency deep sclerotomy (HFDS) PROCEDURE

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.

The participants who received HFDS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead
• Local clinic: collaborator

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Li Min-Zhen, investigator

  IRB of NTUH Hsin-Chu Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ko Mei-Lan, doctor

CONTACT

+886-7265-4211; aaddch@gmail.com

Wang Wei-Xiang, student

CONTACT

+886-6533-5416; wales0315@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants in the arm were suffering from 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.

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 20, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After clinical study report (CSR) are posted; No definite time frame
• Access Criteria: No limit

Locations

TW (1)