Visual function of primary open-angle glaucoma eyes with EDOF intraocular lenses

JRCT ID: jRCTs032200218

Registered date:26/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 26/11/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Implantation of EDOF and monofocal intraocular lens during surgery of cataract and POAG eyes.

Outcome(s)

• Primary Outcome: Evaluate that corrected visual acuity and contrast sensitivity at 3 months after implantation of EDOF intraocular lenses in POAG eyes will be non-inferior to the implantation of monofocal intraocular lenses

Secondary Outcome

1. Explore automated perimetry indexes associating with degradation of visual function (visual acuity and contrast sensitivity) after the EDOF intraocular lenses.
2. Explore a severity level allowing implantation of EDOF intraocular lens
3. Others: product deficiencies than primary and secondary outcomes

Key inclusion & exclusion criteria

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

Include criteria

Patients who meet all of the following criteria are included in this study:
1)Primary open-angle glaucoma (POAG) patients scheduled for cataract surgery
2)Patients who are anticipated to be inserted into and fixed in the capsule
3)Patients for which the calculated lens power is within available range
4)Patients of whom POAG is well controlled, and has no central defect in the visual field and the MD index in the automated perimetry of -10 dB or better
5)Patients who can be followed up after the operation
6)Patients aged 20 years or elder at giving their consent
7)Patients who can understand the content of informed consent documents and can provide written consent form
8)Male and female

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study
1)Patients with eye diseases of uncontrollable glaucoma, progressive diabetic retinopathy, uveitis, retinal detachment, iris neovascularization, and corneal degeneration
2)Patients with eye diseases except for glaucoma and cataract
3)Patients with severe damages in the visual field, such as diffuse, central, and progressive defects
4)Patients with eye diseases that may influence postoperative visual acuity, or patients using medicines that may influence visual acuity
5)Patients with history of corneal surgery
6)Patients who would require complicated surgery due to zonular rupture, posterior capsule rapture, vitreous prolapse, hyphema, incompletion of in-the-bag implantation, etc.
7)Patients who have risks of serious postoperative complications
8)Patients with other physical body or ophthalmic diseases considered unsuitable for participating in the study by an investigator

Related Information

• Primary Sponsor: Bissen Hiroko
• Source(s) of Monetary Support: AMO Japan Ltd