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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013243
Receipt No. R000015426
Scientific Title Efficacy and safety of ExPress glaucoma filtration surgery in normal tension glaucoma
Date of disclosure of the study information 2014/02/24
Last modified on 2020/03/03

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Basic information
Public title Efficacy and safety of ExPress glaucoma filtration surgery in normal tension glaucoma
Acronym Effect of ExPress glaucoma filtration surgery in NTG
Scientific Title Efficacy and safety of ExPress glaucoma filtration surgery in normal tension glaucoma
Scientific Title:Acronym Effect of ExPress glaucoma filtration surgery in NTG
Region
Japan

Condition
Condition Normal tension glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of filtration surgery with ExPress glaucoma filtration device in normal tension glaucoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IOP lowering effect evaluating IOP reduction at 3,6 and 12 months after the surgery compared to the baseline.
The number of cases who have over 20% IOP reduction at 3, 6 and 12 months postoperatively.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 glaucoma filtration surgery with Alcon ExPress glaucoma filtration device model P50PL
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. diagnosed as normal tension glaucoma
2. indication for ExPress glaucoma filtration surgery
3. over 20 years old age when the study agreement was obtained
4. the patients who can understand and agree with the explanatory leaflet and written informed consent verified by IRB.
Key exclusion criteria 1. pregnant and nursing women, and woman desiring future fertility during the study period
2. angle closure and secondary glaucoma
3. subject with a history of glaucoma surgery
4. subject to receive or has received penetrating keratoprasty
5. subject to have a problem for the IOP measurement with GAT
6. diagnosed as corneal dystrophy
7. subject with a history of any ocular surgery within 6 months
8. subject with infectious or non-infectious conjunctivitis, keratitis, or uveitis in one or both eyes
9. diagnosed as severe blepharitis or dry eye
10. subject with a metal allergy
11. judged as inappropriate for study subject
12. subject attended to the other clinical trial or study within 30 days before baseline visit
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Aihara
Organization Shirato Eye Clinic
Division name ophthalmology
Zip code 160-0004
Address 1-1-2 Yotsuya Shinjuku Tokyo, JAPAN
TEL 03-3355-4281
Email aihara-tky@umin.net

Public contact
Name of contact person
1st name Saiko
Middle name
Last name Takayama
Organization Alcon Japan
Division name Reseach development
Zip code 105-6333
Address 1-23-1 Toranomon Minato Tokyo JAPAN
TEL 03-6899-5054
Homepage URL
Email tsunemitsu.senta@alcon.com

Sponsor
Institute Alcon Japan
Institute
Department

Funding Source
Organization Alcon JAPAN
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IEC, Miyata Eye Hospital
Address 6-3, Kuraharacho, Miyakonojo, Miyazaki
Tel 0986-22-1441
Email maruyama@miyata-med.ne.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 24 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/31367979
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/31367979
Number of participants that the trial has enrolled 32
Results
The mean IOP decreased from 14.8+/-2.3 mmHg at baseline to 10.0+/-3.1 mmHg at 12 months after surgery (P<0.0001). IOP reductions>20% were achieved by 61.5% of the eyes at 12 months. Adverse events were typical for filtration procedures, and none was deemed device-related. The mean corneal endothelial cell density had decreased by 3.3% at 12 months after surgery.
Results date posted
2020 Year 03 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eyes with NTG underwent EX-PRESS implantation with or without cataract surgery. 
Participant flow
A total of 37 eyes of 32 patients were enrolled and underwent filtration surgery; these eyes comprised the safety population. Both eyes of five patients underwent filtration surgery; both were included in
the safety analysis but only the eye with the higher baseline IOP (or the right eye if equal) was included in the efficacy analysis.
Adverse events
Postoperative ocular adverse events in the full data set of 37 eyes included choroidal detachment in five eyes (13.5%), hyphema in four (10.8%), corneal epithelial defect in two (5.4%), and epiretinal membrane, macular edema, blebitis, optic disc hemorrhage, and hypotony maculopathy in one eye each (2.7%).  
Outcome measures
Mean IOP at baseline was 14.8 +/- 2.3 mmHg and was significantly reduced from baseline (p<0.0001) at all postoperative time points. Following the immediate postoperative period, IOP stabilized at 1 month, from Month 1 through Month 12, mean IOP ranged from 9.4-0.0 mmHg, mean IOP reductions from 4.9-5.4 mmHg, and percent IOP reductions from 21.1% to 35.4%. At Month 12, mean IOP was 10.0 +/- 3.1 mmHg, a reduction of 4.9 mmHg (31.1%) from baseline (p<0.0001). The proportions of subjects with a minimum 20% IOP reduction from baseline at 3, 6 and 12 months were 72.4%, 82.1%, and 61.5%, respectively. At baseline, all 34 eyes in the efficacy analysis set were on topical IOP-lowering therapy, with a mean of 3.3 +/- 1.0 medications per eye. Between Day 1 and Month 6 postoperatively, no eyes required IOP-lowering medication, and at Month 12, only one eye required topical medical therapy (mean 0.1 medication per eye). Survival analysis defined clinically relevant treatment failure as IOP >/= 12 mmHg or a <20% reduction from baseline at two consecutive study visits. According to this analysis, the cumulative survival rate 12 months after surgery was 55.9%. Mean BCVA over the study period remained unchanged, being 0.115 +/- 0.346 logMAR at baseline and 0.062 +/- 0.250 logMAR at Month 12 (p=0.6196). Mean astigmatism was also unaffected by the procedure, being -1.136 +/- 0.693 D at baseline and -1.635 +/- 0.923 D at Month 12(p=0.092). Mean corneal endothelial cell density decreased from 2658.9 +/- 287.7 cells/mm2 at baseline to 2546.8 +/- 246.1 cells/mm2 12 months after surgery. Although the difference, 95 cells/mm2, was statistically significant (p=0.0095), it represented only a 3.3% reduction in endothelial cell density, which was likely clinically insignificant.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 02 Month 20 Day
Date of IRB
2017 Year 01 Month 05 Day
Anticipated trial start date
2014 Year 03 Month 10 Day
Last follow-up date
2016 Year 10 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2020 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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