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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000022686 |
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Date of registration:
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01/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Clinical Efficacy of Carbonic Anhydrase Inhibitors and Steroids in the Management of Cystoid Macular Edema in Patients with Retinitis Pigmentosa
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Scientific title:
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The Clinical Efficacy of Carbonic Anhydrase Inhibitors and Steroids in the Management of Cystoid Macular Edema in Patients with Retinitis Pigmentosa - The Clinical Efficacy in the Management of Cystoid Macular Edema in Patients with Retinitis Pigmentosa |
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Date of first enrolment:
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2016/07/01 |
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Target sample size:
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40 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026147 |
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Study type:
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Interventional |
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Study design:
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expanded access Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yasuhiro
Ikeda |
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Address:
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3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
8128582
Japan |
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Telephone:
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092-642-5648 |
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Email:
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ymocl@pathol1.med.kyushu-u.ac.jp |
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Affiliation:
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Kyushu University Hospital Department of Ophthalmology |
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Name:
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Yasuhiro
Ikeda |
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Address:
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3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Japan |
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Telephone:
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092-642-5648 |
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Email:
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ymocl@pathol1.med.kyushu-u.ac.jp |
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Affiliation:
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Kyushu University Hospital Department of Ophthalmology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1) a past history of glaucoma or intraocular hypertension (2) patients with another macular disorder, such as epiretinal membrane (3) a past history of using the test drug within 6 months (4) pregnant subjects, subjects suspected of being pregnant, or breast-feeding subjects (5) patients with steroid induced intraocular hypertension (6) hypersensitivity to these test drugs (7) a past history of the entry into another clinical trial within 1 year (8) inappropriate case judged by investigator or subinvestigators
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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retinitis pigmentosa
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Intervention(s)
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1% dorzolamide eye drop three times daily in each eye 0.1% betamethasone sodium phosphate eye drop three times daily in each eye oral 250mg acetazolamide two tablets daily 40mg triamcinolone acetonide into the sub-Tenon capsule
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Primary Outcome(s)
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retinal thickness
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Secondary Outcome(s)
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best-corrected visual acuity, visual field, side effect
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Source(s) of Monetary Support
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Santen Pharmaceutical Co.,Ltd
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Ethics review
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Status: YES
Approval date: 15/06/2016
Contact:
byskenkyu@jimu.kyushu-u.ac.jp
Kyushu University Certified Institutional Review Board
092-642-5082
byskenkyu@jimu.kyushu-u.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2020 |
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URL:
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