UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058049 |
|---|---|
| Receipt number | R000066327 |
| Scientific Title | Correlations between Amyloid-beta Peptide Levels in Aqueous Humor, Retinal Thickness, and Visual Field Loss in Glaucoma Patients |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/06/02 14:28:57 |
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Basic information
Public title
Correlations between Amyloid-beta Peptide Levels in Aqueous Humor and Visual Function in Glaucoma Patients
Acronym
Correlations between Amyloid-beta Levels and Visual Function
Scientific Title
Correlations between Amyloid-beta Peptide Levels in Aqueous Humor, Retinal Thickness, and Visual Field Loss in Glaucoma Patients
Scientific Title:Acronym
Correlations between Amyloid-beta Levels and Visual Function
Region
| Japan |
Condition
Condition
Cataract / Glaucoma / Pseudoexfoliation syndrome / Exfoliation glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate correlations between aqueous humor Amyloid-beta concentrations, retinal nerve fiber layer thickness, and visual field loss in patients with open-angle glaucoma (primary open-angle glaucoma and normal tension glaucoma) and exfoliation glaucoma
Basic objectives2
Others
Basic objectives -Others
Amyloid-beta concentration
Retinal nerve fiber layer thickness
Visual field
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amyloid-beta 1-40 and Amyloid-beta 1-42 concentrations in the aqueous humor collected at the start of cataract or glaucoma surgery and measured using Sensitive and specific enzyme-linked immunosorbent assay (ELISA)
Key secondary outcomes
Correlations between Amyloid-beta 1-40 and Amyloid-beta 1-42 concentrations and retinal nerve fiber layer thickness and degree of visual field loss
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with cataract, glaucoma, pseudoexfoliation syndrome, or exfoliation glaucoma and undergoing cataract or glaucoma surgery
Key exclusion criteria
The patient and/or his/her substitute decision-maker do not provide informed consent for participation in this study, or the patient's ophthalmologist decides not to allow the patient to participate in this study based on the patient's ocular condition.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Ohashi |
Organization
Ohashi Eye Center
Division name
President
Zip code
003-0027
Address
Kita 1-1 Hondori 6, Shiroishi, Sapporo, Hokkaido 003-0027 Japan
TEL
0118644656
ohashi@rainbow.ne.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Ohashi |
Organization
Ohashi Eye Center
Division name
President
Zip code
003-0027
Address
Kita 1-1 Hondori 6, Shiroishi, Sapporo, Hokkaido 003-0027 Japan
TEL
0118644656
Homepage URL
ohashi@rainbow.ne.jp
Sponsor or person
Institute
Ohashi Eye Center
Institute
Department
Personal name
Tsutomu Ohashi
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
MEXT (Japan)
Other related organizations
Co-sponsor
Tokyo Metropolitan Institute of Medical Science, Tokyo, Japan
Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan
Nagoya Eye Clinic, Nagoya, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya Eye Clinic Institutional Review Board
Address
2F COLLECT MARK Kanayama, 24-14 Namiyose-cho, Atsuta-ku, Nagoya, Aichi, Japan
Tel
0528720490
nic-irb@lasik.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
東京都医学総合研究所（東京都）、カレス記念病院（北海道）、名古屋アイクリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
161
Results
Amyloid-beta concentrations in the aqueous humor of patients with exfoliation glaucoma were particularly high and negatively correlated with retinal nerve fiber layer thickness and the degree of visual field loss.
Results date posted
| 2025 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
90 patients in Control Group (cataract only), 32 patients in Glaucoma Group, 22 patients in Pseudoexfoliation Group, 17 patients in Exfoliation glaucoma Group. The mean ages of each group were 73.21+/-8.24, 74.06+/-6.79, 76.45+/-7.28, and 81.18+/-4.46, respectively.
Participant flow
Patients with no pathology other than cataract, glaucoma, pseudoexfoliation syndrome, and exfoliation glaucoma were included. Patients with systemic conditions such as diabetes mellitus and myopia -6 diopters or higher were excluded. The patients were divided into four groups: 32 patients with glaucoma including primary open-angle glaucoma and normal-tension glaucoma (Group GLA); 22 patients with pseudoexfoliation syndrome (Group PEX); 17 patients with exfoliation glaucoma (Group Ex G); and 94 patients with cataract only (Group Control). Patients with an image quality factor less than 45 on SS-OCT and a fixation loss of 20% or higher on Humphrey Field Analyzer were excluded from the mean retinal nerve fiber layer thickness and MD values, and correlation analysis.
Adverse events
None
Outcome measures
Amyloid-beta concentrations in the aqueous humor collected during surgery were measured by enzyme-linked immunosorbent assay (ELISA).
Glaucoma was diagnosed using Swept Source Optical Coherence Tomography and Humphrey Field Analyzer, and defined based on the optic nerve and visual field changes. Correlations between Amyloid-beta concentrations, retinal nerve fiber layer thickness, and visual field loss were evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a prospective comparative study including 129 eyes in 127 patients who underwent cataract surgery and 32 eyes in 27 patients who underwent glaucoma surgery at Ohashi Eye Center or Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan, from October 2022 to May 2025.
Management information
Registered date
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066327
