UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013243
Receipt number 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 11:46:43

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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 or person

Institute

Alcon Japan

Institute

Department

Personal name



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

Value
https://center6.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