UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056430 |
|---|---|
| Receipt number | R000064481 |
| Scientific Title | Evaluation Of Changes In Tear Film Parameters After Upper Eyelid Blepharoplasty By Anterior Segment Optical Coherence Tomography |
| Date of disclosure of the study information | 2024/12/12 |
| Last modified on | 2024/12/12 03:18:15 |
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Basic information
Public title
Evaluation Of Changes In Tear Film Parameters After Upper Eyelid Blepharoplasty By Anterior Segment Optical Coherence Tomography
Acronym
Evaluation Of Changes In Tear Film Parameters After Upper Eyelid Blepharoplasty By Anterior Segment Optical Coherence Tomography
Scientific Title
Evaluation Of Changes In Tear Film Parameters After Upper Eyelid Blepharoplasty By Anterior Segment Optical Coherence Tomography
Scientific Title:Acronym
Evaluation Of Changes In Tear Film Parameters After Upper Eyelid Blepharoplasty By Anterior Segment Optical Coherence Tomography
Region
| Africa |
Condition
Condition
tear film parameters after upper eyelid blepharoplasty
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate tear film parameters after upper eyelid blepharoplasty both objectively using AS-OCT, Schirmer's test and tear break-up time test (TBUT) and subjectively by Ocular Surface Disease Index (OSDI) questionnaire and patient satisfaction score
Basic objectives2
Others
Basic objectives -Others
tear film parameters after upper eyelid blepharoplasty
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Schirmer's test measurements and TBUT significantly decreased at the 1st and 3rd months postoperatively compared to the preoperative measurements, then increased at the 6th month to regain almost the preoperative values. Also, the mean tear meniscus height (TMH) and median tear meniscus area (TMA) significantly decreased after one and three months compared with the preoperative values, then increased after six months. Also, the OSDI score increased significantly at one month postoperatively. Then, it decreased at three months to return to baseline at the end of follow-up.
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
| 42 | years-old | < |
Age-upper limit
| 62 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
. Patients with redundant upper eyelid skin were included in the study
Key exclusion criteria
Excluded patients were those having a history of eyelid surgery, congenital or acquired eyelid malposition, brow ptosis, local ocular surface disease, history of dry eye or topical medications, systemic disease that may affect tear production or ocular surface.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ismail |
| Middle name | |
| Last name | Omar |
Organization
Minia university
Division name
Ophthalmology
Zip code
61111
Address
Minia university hospital
TEL
+201002554116
ismail.omar@mu.edu.eg
Public contact
Name of contact person
| 1st name | Ismail |
| Middle name | |
| Last name | Omar |
Organization
Minia university hospital
Division name
Ophthalmology
Zip code
61111
Address
Minia university hospital
TEL
+201002554116
Homepage URL
ismail.omar@mu.edu.eg
Sponsor or person
Institute
Minia university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Minia university hospital
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Minia university hospital
Address
Minia university hospital
Tel
+201002554116
ismailmoftah1@yahoo.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
50
Results
Schirmer's test measurements and TBUT significantly decreased at the 1st and 3rd months postoperatively compared to the preoperative measurements, then increased at the 6th month to regain almost the preoperative values. Also, the mean tear meniscus height (TMH) and median tear meniscus area (TMA) significantly decreased after one and three months compared with the preoperative values, then increased after six months. Also, the OSDI score increased significantly at one month postoperatively.
Results date posted
| 2024 | Year | 12 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
the mean osdi score significantly increased from baseline preoperative scores to one month postoperatively.
Participant flow
mean age was 47.1 years. 76% were females, and twelve 24% were males.
Adverse events
None
Outcome measures
there was a strong positive correlations between oct measurements and objective tear film tests
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
examination of the patients with AS_OCT after upper eyelid blepharoplasty to study the tear meniscus height and area of these patients before and after surgery
Management information
Registered date
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064481
