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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044150
Receipt No. R000050412
Scientific Title Clinical outcomes of dry-preserved amniotic membrane allograft transplant for ocular surface disease
Date of disclosure of the study information 2021/05/09
Last modified on 2021/05/09

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Basic information
Public title Clinical outcomes of dry-preserved amniotic membrane allograft transplant for ocular surface disease
Acronym DAMAT for OSD
Scientific Title Clinical outcomes of dry-preserved amniotic membrane allograft transplant for ocular surface disease
Scientific Title:Acronym DAMAT for OSD
Region
Asia(except Japan)

Condition
Condition Ocular suface disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical outcomes of dry-preserved amniotic membrane transplantation in Ocular Surface Diseases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1) Rate of retention of dehydrated amniotic membrane/ soft contact lens
2) Pain/Photophobia scale
3) Visual Acuity (BSCVA)
4) External Eye Examination
5) Slit-lamp Examination
Key secondary outcomes Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 single application of dry-preserved amniotic membrane retained by soft contact lenses, Dry-preserved membrane applied once and removed after 2 to 3 week interval
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. ocular surface disease
2. Persistent corneal epithelial defect
3. Thermal/Chemical Burn
4, Corneal ulcer/scar
5, Dry Eye Syndrome
6. Dysfunctional Tear Syndrome
7. Filamentary keratitis
Key exclusion criteria Subjects were excluded from the study if any of the following criteria was fulfilled, corneal or scleral perforation or impending perforation, subjects with recent or active infection, subjects not able to understand the character and individual consequences of the investigation, and participation in other clinical research within the last 8 weeks.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name Harvey
Middle name Siy
Last name Uy
Organization Peregrine Eye and Laser Institute
Division name Research Division
Zip code 1209
Address 5F Morning Star Center, 347 Gil Puyat Avenue, Bel Air, Makati City, Philippines
TEL 63288900115
Email harveyuy@yahoo.com

Public contact
Name of contact person
1st name Angeline
Middle name
Last name Chiong
Organization Peregrine Eye and Laser Institute
Division name Research Section
Zip code 1209
Address 5F Morning Star Center, 347 Gil Puyat Avenue, Bel Air, Makati City, Philippines
TEL 63288900115
Homepage URL http://peregrineeye.com
Email angeline.chiong@peregrineeye.com

Sponsor
Institute Peregrine Eye and Laser Institute
Research Section
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Philippines

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

IRB Contact (For public release)
Organization Peregrine Eye and Laser Institute - Institutional Review Board
Address Peregrine Eye and Laser Institute, 5F Morming Star Center, 347 Gil Puyat Avenue, Bel Air, Makati, Philippines 1209
Tel 63288900115
Email irb@peregrineeye.com

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 Peregrine Eye and Laser Institute, 5F Morming Star Center, 347 Gil Puyat Avenue, Bel Air, Makati, Philippines 1209

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 09 Day

Related information
URL releasing protocol Per request from PI
Publication of results Unpublished

Result
URL related to results and publications Not applicable
Number of participants that the trial has enrolled 30
Results Improved ocular comfort was reported 97%. Mean ocular discomfort score decreased from 3.30 to 1.24 while mean photophobia score decreased from 3.15 to 1.27. Mean LogMAR BCVA improved from 0.42 to 0.25. The AM and SCL remained in position for 94% of eyes. Complete corneal epithelialization was observed in all eyes immediately after SCL removal.
Results date posted
2021 Year 05 Month 09 Day
Results Delayed
Delay expected
Results Delay Reason Pending publication acceptance
Date of the first journal publication of results
Baseline Characteristics Methods. Prospective, non-comparative, interventional case series. Thirty-four (34) eyes of 30 patients with ocular surface disease (OSD) variably characterized by tear deficiency, superficial punctate keratopathy (SPK), and corneal epithelial defects
Participant flow Enrolled eyes underwent ocular surface rehabilitation by DAMAT utilizing processed amniotic membrane (AmnioTek C, ISP Surgical, Boston, MA). The DAM was retained using conventional soft contact lenses (SCL) for 2 to 3 weeks after which the SCL was removed. Patients were followed up 2 months after AM/SCL application.
Adverse events Eight of 34 (24%) eyes required repeat DAMT after SCL removal due to recurrence of epithelial defects or ocular discomfort. One (3%) eye required AM/SCL reapplication due to spontaneous displacement. One (3%) eye required AM/SCL removal due to intolerable foreign body sensation. No serious adverse reactions related to either AM or SCL were observed.
Outcome measures Main outcome measures: Ocular discomfort score, photophobia score, best-corrected visual acuity (BCVA), AM/SCL retention, corneal re-epithelialization and quality after SCL removal, reapplication rate and adverse events.
Plan to share IPD Per request from PI
IPD sharing Plan description Per request from PI: harveyuy@yahoo.com

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 03 Month 11 Day
Date of IRB
2015 Year 12 Month 15 Day
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
2018 Year 07 Month 15 Day
Date of closure to data entry
2018 Year 12 Month 01 Day
Date trial data considered complete
2018 Year 12 Month 15 Day
Date analysis concluded
2020 Year 04 Month 15 Day

Other
Other related information

Management information
Registered date
2021 Year 05 Month 09 Day
Last modified on
2021 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050412

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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