An interventional study of High frequency deep sclerotomy (HFDS) in Primary Open Angle Glaucoma, Intraocular Pressure and Glaucoma Surgery, sponsored by National Taiwan University Hospital Hsin-Chu Branch. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by National Taiwan University Hospital Hsin-Chu Branch · Not applicable, Interventional, and Treatment
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.
[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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 30 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
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)
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.
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.
Time frame: Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.
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.
Time frame: Postoperative day 1, day 7, day 14, 1st month, 2nd month, 3rd months, 4th month, 5th month and 6th months.
Plan to share: Yes — Clinical Study Report (CSR) can be shared
Supporting information: Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital Hsin-Chu Branch