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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034416
Receipt No. R000039243
Scientific Title Effect of topical antiglaucoma medications on prevention for intraocular pressure elevation after cataract surgery in eyes with glaucoma : a randomized clinical comparative study.
Date of disclosure of the study information 2018/10/09
Last modified on 2018/11/12

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Basic information
Public title Effect of topical antiglaucoma medications on prevention for intraocular pressure elevation after cataract surgery in eyes with glaucoma : a randomized clinical comparative study.
Acronym Topical antiglaucoma agents against IOP elevation after cataract surgery
Scientific Title Effect of topical antiglaucoma medications on prevention for intraocular pressure elevation after cataract surgery in eyes with glaucoma : a randomized clinical comparative study.
Scientific Title:Acronym Topical antiglaucoma agents against IOP elevation after cataract surgery
Region
Japan

Condition
Condition Open-angle glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of topical prostaglandin F2A analogue (PGF), B-blocker, and carbonic anhydrase inhibitor (CAI) on prevention for intraocular pressure (IOP) elevation after cataract surgery in eyes with glaucoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes IOP was measured using a rebound tonometer at 1 hour preoperatively; at the end of surgery (surgically adjusted to range between 15 and 25 mmHg); and at 2, 4, 6, 8, and 24 hours postoperatively.
Key secondary outcomes 1) Static visual fields sensitivity with 30-2 program of the Humphrey Field Analyzer.
2) Flare intensity at 6 hours after surgery
3) Wound states determined using anterior segment-optical coherence tomography
4) Visual acuity, refraction, corneal astigmatism

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 55 eyes of 55 patients who received topical prostaglandin F2A analogue just after surgery (Travoprost 0.004%, Travatanz; Alcon Pharmaceutical; Fort Worth, TX, USA).
Interventions/Control_2 55 eyes of 55 patients who received topical B-blocker just after surgery (0.5% Timolol maleate, Timoptol; Santen Pharmaceutical, Tokyo, Japan).
Interventions/Control_3 55 eyes of 55 patients who received topical carbonic anhydrase inhibitor (CAI) just after surgery (Brinzolamide 2%, Azopt; Alcon).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Clinical research coordinators began screening of all consecutive eyes with medically well-controlled POAG or pseudoexfoliation glaucoma with topical antiglaucoma agents (an IOP of 21 mmHg or less at 2 continuous prior visits) that were scheduled for phacoemulsification with implantation of a hydrophobic acrylic intraocular lens (IOL).
Key exclusion criteria Exclusion criteria were 1) eyes with any ocular pathology other than cataract and glaucoma; 2) eyes scheduled for planned extracapsular or intracapsular cataract extraction; 3) history of previous ocular surgery or inflammation; 4) patients with contraindication for administration of prostaglandin F2A analogues, B-blockers, topical carbonic anhydrase inhibitor; 5) patient refusal; 6) any anticipated difficulties with examination or follow-up; and 7) patients who were included in another study.
Target sample size 165

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Hayashi
Organization Hayashi Eye Hospital
Division name Department of Ophthalmology
Zip code
Address 4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
TEL 092-431-1680
Email hayashi-ken@hayashi.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Hayashi
Organization Hayashi Eye Hospital
Division name Department of Ophthalmology
Zip code
Address 4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
TEL 092-431-1680
Homepage URL
Email hayashi-ken@hayashi.or.jp

Sponsor
Institute Hayashi Eye Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 林眼科病院(福岡県/Hayashi Eye Hospital (Fukuoka)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 09 Month 21 Day
Date of closure to data entry
2018 Year 09 Month 25 Day
Date trial data considered complete
2018 Year 09 Month 25 Day
Date analysis concluded
2018 Year 10 Month 06 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 09 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039243

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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