UMIN-CTR Clinical Trial

Basic information
Public title	Clinical outcomes of scleral intraocular lens fixation
Acronym	Clinical outcomes of scleral intraocular lens fixation
Scientific Title	Clinical outcomes of scleral intraocular lens fixation
Scientific Title:Acronym	Clinical outcomes of scleral intraocular lens fixation
Region	Japan

Condition
Condition	aphakia, intralocular lens dislocation, lens dislocation
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To report the clinical outcomes of intrascleral fixation of an intraocular lens
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraocular lens dislocation, tilt
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The intraocular lens haptic is pulled out of the sclera by the single needle method.
Interventions/Control_2	The intraocular lens haptic is pulled out of the sclera by the double needle method.
Interventions/Control_3	The intraocular lens haptic is pulled out of the sclera by the vitreous forceps.
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	20 years-old <=
Age-upper limit	120 years-old >
Gender	Male
Key inclusion criteria	Patients in which visual function is impaired due to aphakia, intraocular lens dislocation, lens dislocation.
Key exclusion criteria	The exclusion criteria were retinal disease requiring treatment, such as retinal detachment or macular pucker; preoperative intraocular pressure (IOP) of 25 mmHg or more while receiving treatment with eye drops; scleritis; age younger than 20 years
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tatsushi Middle name Last name Kaga
Organization	Chukyo Hospital
Division name	Opthalomology
Zip code	4578510
Address	1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aichi
TEL	052-691-7151
Email	kaga@chukyogroup.jp

Public contact
Name of contact person	1st name Hayato Middle name Last name Mitamura
Organization	Chukyo Hospital
Division name	Opthalomology
Zip code	4578510
Address	1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aichi
TEL	052-691-7151
Homepage URL
Email	mitamura@chukyogroup.jp

Sponsor
Institute	Chukyo Hospital
Institute
Department

Funding Source
Organization	Chukyo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japan Community Health care Organization
Address	1 Chome-1-10 Sanjo, Minami Ward, Nagoya, Aic
Tel	052-691-7151
Email	mitamura@chukyogroup.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2020019
Org. issuing International ID_1	Chukyo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 17 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	63
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	Open public recruiting
Date of protocol fixation	2020 Year 12 Month 17 Day
Date of IRB	2020 Year 06 Month 25 Day
Anticipated trial start date	2020 Year 12 Month 17 Day
Last follow-up date	2022 Year 12 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 12 Day
Last modified on	2021 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048769