QoL Assessment in Traditional Glaucoma Surgery and MIGS.
Primary Purpose
Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Glaucoma surgery
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma focused on measuring MIGS, canaloplasty, glaucoma, glaucoma surgery, glaucoma implant, deep sclerectomy, iridencleisis, QoL, quality of life, NEI VFQ 25
Eligibility Criteria
Inclusion Criteria:
patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:
- all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
- patients not tolerating antiglaucoma medications,
- patients with poor compliance
- progression in visual field
Exclusion Criteria:
- active inflammatory disease
- pregnancy
- mental disease or emotional instability
- general steroid therapy
- inability to fill in the questionnaire
Sites / Locations
- Military Institute of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
traditional glaucoma surgery
microinvasive glaucoma surgery (MIGS)
Arm Description
glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy
glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device
Outcomes
Primary Outcome Measures
NEI VFQ 25 quality of life score change
NEI VFQ 25 baseline and 3 months after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT03613233
First Posted
June 29, 2018
Last Updated
July 29, 2018
Sponsor
Military Institute od Medicine National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03613233
Brief Title
QoL Assessment in Traditional Glaucoma Surgery and MIGS.
Official Title
Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Institute od Medicine National Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).
Detailed Description
Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
MIGS, canaloplasty, glaucoma, glaucoma surgery, glaucoma implant, deep sclerectomy, iridencleisis, QoL, quality of life, NEI VFQ 25
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional glaucoma surgery
Arm Type
Active Comparator
Arm Description
glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy
Arm Title
microinvasive glaucoma surgery (MIGS)
Arm Type
Active Comparator
Arm Description
glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device
Intervention Type
Procedure
Intervention Name(s)
Glaucoma surgery
Other Intervention Name(s)
cataract surgery when required
Intervention Description
phacoemulsification
Primary Outcome Measure Information:
Title
NEI VFQ 25 quality of life score change
Description
NEI VFQ 25 baseline and 3 months after surgery
Time Frame
baseline (0-30 days; pre-operative) and three months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:
all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
patients not tolerating antiglaucoma medications,
patients with poor compliance
progression in visual field
Exclusion Criteria:
active inflammatory disease
pregnancy
mental disease or emotional instability
general steroid therapy
inability to fill in the questionnaire
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Byszewska, MD, PhD
Phone
500285890
Ext
48
Email
ania.byszewska@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marek Rękas, prof.; MD; PhD
Email
mrekas@wim.mil.pl
Facility Information:
Facility Name
Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Byszewska, MD,PhD
Phone
500285890
Ext
48
Email
ania.byszewska@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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QoL Assessment in Traditional Glaucoma Surgery and MIGS.
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