UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034416 |
|---|---|
| Receipt number | 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 11:28:59 |
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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
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
hayashi-ken@hayashi.or.jp
Sponsor or person
Institute
Hayashi Eye Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039243
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
