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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2072200052

Registered date:13/11/2020

Clinical Investigation of POD F GF

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedCataract
Date of first enrollment26/10/2020
Target sample size22
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Cataract Surgery

Outcome(s)

Primary Outcome-Best corrected distance visual acuity (5 m) at Visit 4A (Postoperative Day 120-180) -Distance corrected near visual acuity (40 cm) at Visit 4A (Postoperative Day 120-180) -Distance corrected intermediate visual acuity (80 cm) at Visit 4A (Postoperative Day 120-180)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria- Subject with preoperative astigmatism < 1.0 D - The subject must be able to undergo second eye surgery within 30 days of the first eye surgery. - Other protocol-specified inclusion criteria may apply.
Exclude criteria- Irregular corneal aberration that affects postoperative visual function as demonstrated by corneal topography; - Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.5 decimal for CDVA; - Subjects who may be expected to require ocular surgery (other than blepharo-surgery, laser surgery of fundus and YAG capsulotomy) during the study; - Previous refractive surgery; - Other protocol-defined exclusion criteria may apply.

Related Information

Contact

Public contact
Name Tsunemitsu Senta
Address 2-8 Kojimachi, Chiyoda-ku, Tokyo Tokyo Japan 102-0083
Telephone +81-3-5214-2277
E-mail tsenta@bvimedical.com
Affiliation Beaver-Visitec International Japan
Scientific contact
Name Naoyuki Maeda
Address 1-51-10 Hannancho Abeno-ku, Osaka-shi, Osaka-fu Osaka Japan 545-0021
Telephone +81-6-6621-2174
E-mail maeda@kozaki-ganka.jp
Affiliation Kozaki Eye Clinic