UMIN-CTR Clinical Trial

Public title

A study of the association between spectacle prescription and newly detected suspected or definite glaucoma

Acronym

Spectacle Prescription and Glaucoma Study

Scientific Title

Association of distance refractive prescription and near addition power with newly detected glaucomatous abnormalities: a cross-sectional study

Scientific Title:Acronym

Refractive Prescription, Near Addition, and Glaucomatous Abnormalities Study

Region

Japan

Condition

Glaucoma and suspected glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective is to investigate the associations of distance spherical equivalent (SE), near SE, near addition power (ADD), and prescription-type, with newly detected glaucomatous abnormalities in patients aged 35 years or older presenting at an ophthalmology clinic for spectacle prescription.

Basic objectives2

Others

Basic objectives -Others

As part of a staged glaucoma screening process, Optical Coherence Tomography (OCT)-which uses light to image the thickness of the retina and optic nerve-will be performed on all participants. For a subset of patients whose OCT results are normal and who do not require visual field testing as part of routine clinical care, a visual field test by Humphrey Field Analyzer (HFA) testing will be additionally conducted for research purposes to conduct an exploratory evaluation of the diagnostic value, feasibility, and safety of the staged glaucoma screening pathway.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Association between distance SE and newly detected glaucomatous abnormalities at the participant level, assessed on completion of the enrollment-related clinical examinations. An abnormality is defined as code 2 (suspected glaucoma requiring follow-up or further testing) or code 3 (definite glaucoma requiring treatment or specialist management) in at least one eye. Participants with code 1 in both eyes are classified as having no abnormality. SE is calculated as the prescribed spherical power plus half the cylindrical power; the lower of the two eyes' SE values is used in participant-level analyses. Adjusted odds ratios with 95% confidence intervals will be estimated by multivariable logistic regression, with adjustment for age, sex, study site, and intraocular pressure in the selected eye.

Key secondary outcomes

The following will be assessed on completion of the enrollment-related clinical examinations:
1. Proportion of participants with definite glaucoma (code 3 in at least one eye) and its association with distance SE.
2. Frequency of newly detected glaucomatous abnormalities in the right and left eyes separately, and exploratory associations with SE and intraocular pressure in the same eye.
3. Proportion of newly detected glaucomatous abnormalities within each distance SE category.
4. Exploratory associations of near SE, ADD, and spectacle prescription type with newly detected glaucomatous abnormalities.
5. Numbers and proportions of participants in visual field pathways A-D, and distributions of final diagnostic codes.
6. Frequency of abnormal findings on additional HFA in Group C, and proportion classified as code 2 or 3 after comprehensive assessment.
7. Rates of offering, undergoing, declining, being unable to perform, completing, and discontinuing additional HFA testing.
8. Occurrence of adverse events and test discontinuation during and immediately after additional HFA testing.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Refractive prescription indices, intraocular pressure, ocular imaging, clinically indicated visual field testing, and final diagnoses will be collected from routine care for all participants. A subset of patients with normal OCT findings in both eyes who would not otherwise require visual field testing in routine care will be selected as candidates for Group C, according to a prespecified procedure of one candidate each in the morning and afternoon. Following written informed consent to participate in the study, additional research-purpose HFA will be performed in those who agree to the examination. Declining additional HFA will not disadvantage the patient in routine care or in continued study participation. Additional HFA will be performed as part of the enrollment-related assessment; no long-term repeated testing is planned as the research intervention. HFA testing will use the 30-2 test pattern, which measures the area within a 30-degree radius from the center, and the Swedish Interactive Thresholding Algorithm (SITA) Fast algorithm, which predicts and calculates the next stimulation level based on the patient's response. This will shorten the examination time, with one test per eye in principle. If reliability is judged inadequate, the affected eye will be retested on the same day with the same settings.

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

Age-lower limit

35

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients are eligible if they meet all the following criteria:
1. Patients aged 35 years or older presenting at a participating study site for a spectacle prescription.
2. Patients who have received an explanation of the study and provided written informed consent.
3. Patients who have undergone refraction, non-contact tonometry, and optic disc OCT imaging.
4. Patients with no previous diagnosis of glaucoma and no history of examination for suspected glaucoma.
5. Patients with distance or near spectacle prescription data available for at least one eye.

Key exclusion criteria

Patients will be excluded if they meet any of the following criteria:
1. Treatment or follow-up for previously diagnosed glaucoma.
2. A history of examination for suspected glaucoma.
3. Any of the following conditions in either eye:
(1) Previous cataract surgery with Intraocular Lens (IOL) Implantation.
(2) Previous implantation of an Implantable Collamer Lens (ICL).
(3) Previous corneal refractive surgery, including Laser-Assisted in Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), or Small Incision Lenticule Extraction (SMILE).
(4) Previous corneal surgery affecting refraction or corneal shape, including corneal transplantation or intrastromal corneal ring implantation.
(5) Corneal disease affecting the assessment of refraction or corneal shape, including keratoconus, corneal opacity or scarring, or irregular astigmatism.
(6) Previous glaucoma surgery, including filtration surgery, glaucoma drainage device implantation, or minimally invasive glaucoma surgery.
4. Difficulty understanding or undergoing the required examinations owing to dementia, communication difficulties, cognitive impairment, psychiatric symptoms, or similar conditions.
5. Inability to undergo the examinations required for study assessment owing to reduced physical strength, difficulty maintaining posture, movement disorders, poor general health, or similar conditions.
6. Difficulty assessing glaucomatous optic neuropathy or visual field defects, as judged by the attending ophthalmologist, owing to retinal disease, optic nerve disease, significant cataract, or similar conditions.
7. Refusal to permit use of the information required for the study.

Target sample size

10000

Name of lead principal investigator

1st name	Eiichi
Middle name
Last name	Okada

Organization

Okada Eye Clinic

Division name

Ophthalmology

Zip code

2340054

Address

5-5-22, Konandai, Konan Ward, Yokohama City, Kanagawa Prefecture, Japan.

TEL

+81-45-832-0808

Email

okadaeiichi@hotmail.com

Name of contact person

1st name	Hiroyuki
Middle name
Last name	Okada

Organization

Okada Eye Clinic

Division name

Ophthalmology

Zip code

2340054

Address

5-5-22, Konandai, Konan Ward, Yokohama City, Kanagawa Prefecture, Japan.

TEL

+81-45-832-0808

Homepage URL

Email

okadahiroyuki.0903.tokai@gmail.com

Institute

Okada Eye Clinic

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Department of Ophthalmology and Visual Science, Yokohama City University Graduate School of Medicine
Department of Public Health, Kyorin University School of Medicine

Name of secondary funder(s)

Organization

Okada Eye Clinic

Address

5-5-22, Konandai, Konan Ward, Yokohama City, Kanagawa Prefecture, Japan.

Tel

+81-45-832-0808

Email

mail@tokaimegane.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岡田眼科（神奈川県）、横浜西口眼科（神奈川県）

Date of disclosure of the study information

2026

Year

10

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

0

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

There is no plan to share IPD.

IPD sharing Plan description

Individual participant data will not be shared with researchers outside this study. Study data will be shared among participating institutions only as needed to conduct the study, in accordance with the approved protocol and participant consent.

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

01

Day

Date of IRB

2026

Year

10

Month

01

Day

Anticipated trial start date

2026

Year

12

Month

01

Day

Last follow-up date

2031

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is an exploratory, non-randomized, open-label, uncontrolled, cross-sectional study with consecutive enrollment at two ophthalmology clinics, with additional research-purpose HFA testing in a subset of participants. The target sample size is 10,000 participants (up to 20,000 eyes). Associations between enrollment-related refractive indices and final diagnoses will be assessed, but incident glaucoma and incidence rates will not. The primary analysis will use participant-level multivariable logistic regression. Eye-level analyses will pair each eye's SE with the diagnosis for that eye. Statistical analysis will not treat the two eyes of a participant as independent. Group C is an exploratory subset undergoing additional testing, selected by time of day from patients with normal OCT findings. Its results will not be used to estimate the sensitivity, specificity, or negative predictive value of OCT, or general-population prevalence. Only aggregate counts, reasons, and age-category and sex distributions for nonparticipants will be compiled locally; no individual-level research dataset will be created for them. The study is funded internally by Okada Eye Clinic; there are no conflicts of interest to disclose.

Registered date

2026

Year

10

Month

15

Day

Last modified on

2026

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072439