Performance of Extended Depth of Focus (EDOF) multifocal SCL for intraocular lens implanted eyes

JRCT ID: jRCTs032200118

Registered date:14/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: IOL implanted eyes after cataract surgery
• Date of first enrollment: 10/10/2020
• Target sample size: 17
• Study type: Interventional
• Intervention(s): Multifocal soft contact lens

Outcome(s)

• Primary Outcome: Visual acuity at various distances at contrast sensitivity of 100%

Secondary Outcome

- Visual acuity at various distances at contrast sensitivity of 40% and 20%
- Visual acuity at far and near in open filed
- Contrast sensitivity with stripe vision chart
- Stereopsis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

-Men and women who understand the contents of the consent explanation document and their informed consents can be obtained.
-Those whose ages are between 20 and 75
-Those who had undergone cataract surgery 1 month ago or before
-Those who have monofocal or toric intraocular lenses inserted in both eyes
-Those have spherical equivalent from 0.00 to -6.00D by refraction test
-Those who require near or far vision correction
-Those who have a total astigmatism of 1.00D or less in both eyes by refraction test
-Those who have corrected distance vision in both eyes of 0.7 or better (decimal visual acuity)

Exclude criteria

- Patients with moderate or severe grade of corneal/conjunctival or eyelid abnormalities
- Patients with uveitis
- Patients with dry eye and lacrimal disease that are problematic for lens wear
- Patients with allergic diseases that can affect lens wear
- Patients with diabetics
- Patients with a history of anaphylaxis
- Patients with serious cardiac, hepatic, renal, pulmonary, hematological disorders and other complications that are considered inappropriate for the study.
- Patients who have participated in other trials within the last 3 months
- Pregnant women, women who are breastfeeding or plan to become pregnant during the study
- Patients who used hard contact lens (including Orthokeratology lens) within the last 1 month
- Patients who wear contact lenses in 1 eye only.
- Patients who are judged to be ineligible for the study by the investigators and those are considered unsuitable for wearing soft contact lenses by the investigators.

Related Information

• Primary Sponsor: Takahiro Hiraoka
• Source(s) of Monetary Support: Seed Co., Ltd.