UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044150 |
|---|---|
| Receipt number | 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 13:10:36 |
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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
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
angeline.chiong@peregrineeye.com
Sponsor or person
Institute
Peregrine Eye and Laser Institute
Research Section
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050412
