UMIN-CTR Clinical Trial

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

Normal tension glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Alcon Japan

Institute

Department

Personal name

Organization

Alcon JAPAN

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

IEC, Miyata Eye Hospital

Address

6-3, Kuraharacho, Miyakonojo, Miyazaki

Tel

0986-22-1441

Email

maruyama@miyata-med.ne.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

02

Month

24

Day

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/31367979

Publication of results

Published

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

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 related 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