UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Title of the study (Brief title)	Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Region	Japan

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

Objectives
Narrative objectives1	To compare the predictability of intraocular lens (IOL) power calculation using several corneal power measurements in eyes underwent phototherapeutic keratectomy (PTK).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IOL power calculations were performed by the SRK/T formula using Total Corneal Refractive Power
Key secondary outcomes	Automated keratometry, Simulated keratometry, True Net Power

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	65 years-old <=
Age-upper limit	88 years-old >=
Gender	Male and Female
Key inclusion criteria	total of 42 eyes of 25 consecutive patients
Key exclusion criteria	Eyes with postoperative best spectacle-corrected visual acuity (BCVA) of >0.25 logMAR, and eyes with any history of ocular surgery, ocular trauma, or other concomitant eye diseases, were excluded from the study.
Target sample size	25

Research contact person
Name of lead principal investigator	Kazutaka Kamiya
Organization	Kitasato University
Division name	Ophthalmology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0373, Japan
TEL	+81-42-778-9012
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	Ryo Yoneyama
Organization	Kitasato University
Division name	Ophthalmology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0373, Japan
TEL	+81-42-778-9012
Homepage URL
Email	ryone.ry0@gmail.com

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Self funding
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	2019 Year 01 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 22 Day
Anticipated trial start date	2018 Year 05 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	Published
URL releasing results
Results
Other related information	Approval number:B17-362

Management information
Registered date	2019 Year 01 Month 17 Day
Last modified on	2019 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040535