UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of topical antiglaucoma medications on prevention for intraocular pressure elevation after cataract surgery in eyes with glaucoma : a randomized clinical comparative study.
Title of the study (Brief title)	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	Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of Ophthalmology
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	Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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