UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Outcomes of Phototherapeutic Keratectomy Using Anti CI program.
Title of the study (Brief title)	Outcomes of Phototherapeutic Keratectomy Using Photorefractive Keratectomy Mode.
Region	Japan

Condition
Condition	band keratopathy and granular corneal dystrophy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the outcomes of phototherapeutic keratectomy (PTK) using anti-central island (CI) program and to compare visual acuity and the rate of CI after PTK with and without CI program.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative Visial acurity
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Eligibility
Age-lower limit	38 years-old <=
Age-upper limit	92 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who had PTK for corneal degeneration at Kitasato University Hospital
Key exclusion criteria	Patients with other corneal diseases, active uveitis, glaucoma, ocular floor disease
Target sample size	100

Research contact person
Name of lead principal investigator	Kazutaka Kamiya
Organization	Kitasato University Hospital
Division name	Ophthalmology
Address	1-15-1 Kitasato Minami-ku Sagamihara-shi
TEL	0427788111
Email	ads00133@gmail.com

Public contact
Name of contact person	Masahide Takahashi
Organization	Kitasato University Hospital
Division name	Ophthalmology
Address	1-15-1 Kitasato Minami-ku Sagamihara-shi
TEL	0427788111
Homepage URL
Email	zavide96@gmail.com

Sponsor
Institute	Kitasato University Hospital
Institute
Department

Funding Source
Organization	Kitasato University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 23 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 04 Month 22 Day
Anticipated trial start date	2018 Year 04 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	The use of the anti-CI program for PTK with the VISX Star S4 excimer laser system significantly decrease the rate of CI formation, in association with the improvement of visual acuity.

Management information
Registered date	2018 Year 04 Month 23 Day
Last modified on	2018 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036895