Multicenter study to evaluate glaucoma detection ability by new visual field test program (SITA Standard 24-2C)

JRCT ID: jRCTs032210411

Registered date:05/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Glaucoma or suspected glaucoma
• Date of first enrollment: 01/12/2022
• Target sample size: 50
• Study type: Interventional

Intervention(s)

1) Basic data determination, explanatory consent, and registration in regular medical treatment before entry (visit 1)
Confirmation of the background of the research subject, subjective symptoms and other findings. Confirmation of whether the subject has ever undergone visual acuity, refraction, intraocular pressure, and normal static visual field examination (SITA Standard 24-2) performed in routine glaucoma care, and adoption of the most recent data within 6 months. After the decision is made, the patient will be explained using the explanatory document and written consent will be obtained.

2) Day 1 of the examination (visit 2)
Subjective symptoms and other findings, normal glaucoma examination (visual acuity, intraocular pressure, etc.), visual field test, and SITA Standard 24-2C, SITA Faster 24-2C, and SITA Standard 10-2 programs will be performed randomly (if the reliability index is below the standard value, the corresponding test will be performed again). After mydriasis, OCT examination and CLARUS stereoscopic fundus photography are performed.

3) Examination day 2 (within 1 month of examination day 1; visit 3)
Subjective symptoms and other findings, normal glaucoma examination (visual acuity, intraocular pressure, etc.), visual field test, and SITA Standard 24-2C, SITA Faster 24-2C, and SITA Standard 10-2 programs are performed randomly.

Outcome(s)

• Primary Outcome: The sensitivity thresholds, the occurrence rate of anomaly probability plots, and the Mean Deviation values for the entire visual field at each measurement point obtained by the SITA Standard 24-2C program will be examined.The comparison programs will be SITA Faster 24-2C, SITA Standard 24-2, and 10-2.

Secondary Outcome

1) Examine the inspection time for each program
Evaluate the inspection time of the new program and examine the validity of the added inspection points.
2) Examination of the correspondence between structure and function
Optical coherence tomography (OCT) and stereoscopic fundus photography will be performed in conjunction, and the validity of the detected visual field abnormalities (abnormalities in function) will be evaluated by comparing them with structural changes in the retina.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with glaucoma or suspected glaucoma on regular visits to the hospital
2) Patients with or without treatment.
3) Patients who have previously undergone HFA visual field testing (SITA Standard 24-2 program) and have an MD of -25D or higher and corrected visual acuity of 0.5 or higher
(4) Age: Those who are 20 years old or older at the time of obtaining consent.
5) Gender: Any.
(6) Those who have received sufficient explanations about participation in this study, and have given written consent of their own free will with sufficient understanding.
(7) Those who are able to attend outpatient clinics according to the research implementation schedule

Exclude criteria

1) Patients who did not give consent to participate in this study
2) Eyes with ocular findings that affect the visual field other than glaucoma, or eyes that have previously undergone internal eye surgery other than cataract or glaucoma
3) Other patients who are judged by the principal investigator to be inappropriate for participation in this study.

Related Information

• Primary Sponsor: Nakano Tadashi
• Source(s) of Monetary Support: Carl Zeiss Meditec Co. Ltd.