Establishment of an Objective and Quantitative Design System for Shading Glasses 2

JRCT ID: jRCT1032220516

Registered date:16/12/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Retinitis pigmentosa
• Date of first enrollment: 16/12/2022
• Target sample size: 6
• Study type: Interventional
• Intervention(s): measure the contrast sensitivity by Pelli-Robson chart for the subjects wearing the colored filter lenses selected based on the basic theory

Outcome(s)

• Primary Outcome: Contrast sensitivity with wear confirmation test device

Secondary Outcome

1) best corrected logMAR visual acuity
2) central 4 point mean retinal sensitivity and mean deviation value of Humphrey field analyzer perimetry 10-2 program

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) patients with retinitis pigmentosa, 20 years of age or more and under 80 years of age at the time of obtaining informed concent
2) patients with decimal visual acuity of 0.1 or more
3) patients who have used colored filter lenses to reduce photophobia
4) patients who participated in the previous exploratory study 1.
5) patients who have given written consent based on their own free will after receiving a sufficient explanation for participating in this study.

Exclude criteria

1)patiens with complications as follows: macular disease with vitreous macular traction syndrome/macular edema/epiretinal membrane/severe myopia with macular legions, diabetic retinopathy, inflamation of external eye/infection/severe dry eye, occlusion of retinal artery, posterior ischemic optic neuropathy, history of optic nerve disease, nuclear cataract (Grade 3 or higher by Emery clasification), pre-subcapsular cataract or posterior subcapsular cataract seriously affecting the vision
2) patients who the Principal Investigator or the investigating doctors judging inappropriate for participation in this trial

Related Information

• Primary Sponsor: Miura Gen
• Source(s) of Monetary Support: Mitsui Chemicals, Inc.