UMIN-CTR Clinical Trial

Basic information
Public title	Refractive analysis using AS-OCT.
Acronym	Refractive analysis using AS-OCT.
Scientific Title	Refractive analysis using AS-OCT.
Scientific Title:Acronym	Refractive analysis using AS-OCT.
Region	Japan

Condition
Condition	Keratoconus
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Quantitative Evaluation of the Natural Progression of Keratoconus Using Three-Dimensional Optical Coherence Tomography
Basic objectives2	Others
Basic objectives -Others	Quantitative Evaluation of the Natural Progression of Keratoconus
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	TCT, CCT, BFS_R, Kmax
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	10 years-old <=
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	Without active ocular surface disease.
Key exclusion criteria	With active ocular surface disease.
Target sample size	113

Research contact person
Name of lead principal investigator	1st name Hisataka Middle name Last name Fujimoto
Organization	Osaka University
Division name	Department of Ophthalmology
Zip code	701-0192
Address	Room E7, 2-2 Yamadaoka, Suita, Osaka 565-0871,
TEL	0668795432
Email	fujimohis@yahoo.co.jp

Public contact
Name of contact person	1st name Hisataka Middle name Last name Fujimoto
Organization	Osaka University
Division name	Department of Ophthalmology
Zip code	565-0871
Address	Room E7, 2-2 Yamadaoka, Suita, Osaka 565-0871,
TEL	0668795432
Homepage URL
Email	fujimohis@yahoo.co.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Osaka University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University
Address	Room E7, 2-2 Yamadaoka, Suita, Osaka 565-0871,
Tel	0668795432
Email	fujimohis@yahoo.co.jp

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	2021 Year 11 Month 11 Day

Related information
URL releasing protocol	https://iovs.arvojournals.org/article.aspx?articleid=2535984
Publication of results	Published

Result
URL related to results and publications	https://iovs.arvojournals.org/article.aspx?articleid=2535984
Number of participants that the trial has enrolled	113
Results	Annual changes in Rpost (mean, -0.017 mm) and Tmin (-2.69 um) were significantly higher in younger patients (P < 0.01, GEE nonlinear regression) and in patients with higher maximal K value (Kmax; P < 0.01, GEE nonlinear regression)
Results date posted	2021 Year 11 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2016 Year 04 Month 23 Day
Baseline Characteristics	Patients with keratoconus, KCS, or forme fruste keratoconus (FFK) and normal controls of healthy subjects were recruited at the Osaka University Hospital, Osaka
Participant flow	We examined 217 corneas in 113 patients, comprising 189 corneas from 109 patients with keratoconus, 14 corneas of 12 patients with KCS, and 14 corneas of 14 patients with FFK. In addition, 23 corneas of 16 normal controls of healthy subjects were included.
Adverse events	We examined 217 corneas in 113 patients, comprising 189 corneas from 109 patients with keratoconus, 14 corneas of 12 patients with KCS, and 14 corneas of 14 patients with FFK. In addition, 23 corneas of 16 normal controls of healthy subjects were included.
Outcome measures	The best-fit spheres (BFS) were computed for the anterior and posterior corneal surfaces, and differences between fitted surfaces and real data were plotted as elevation maps. Tomographic maps of corneal thickness also were displayed. Minimum corneal thickness (Tmin) was defined as the pachymetric value at the thinnest location.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 16 Day
Date of IRB	2013 Year 10 Month 16 Day
Anticipated trial start date	2013 Year 10 Month 16 Day
Last follow-up date	2015 Year 10 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Osaka University

Management information
Registered date	2021 Year 11 Month 11 Day
Last modified on	2021 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052546