NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs072190056

Registered date:27/03/2020

Comparison of incidences of AMD after implantation of IOLs with and without blue light blocking.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCataract
Date of first enrollment18/06/2020
Target sample size278
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Group A: Implantation of a intraocular lens with blue light blocking Group B: Implantation of a intraocular lens without blue light blocking

Outcome(s)

Primary OutcomeThe incidence of wet-AMD for 3 years after surgery
Secondary Outcome1) Compare the incidence of fundus abnormalities determined via fundus photography, FAF, OCT, OCTA or fluorescein angiography. 2) Since the amount of visible light transmitted through the eye may differ depending on the pupil diameter, the pupil diameter is compared between the two groups. 3) Compare the transition of distant corrected visual acuity after surgery.

Key inclusion & exclusion criteria

Age minimum>= 50age old
Age maximum<= 75age old
GenderBoth
Include criteria1) Patients without AMD nor its precursor lesions who are able to receive an ocular fundus examination before cataract surgery 2) Patients aged 50 years or older and below 75 years who are planned for cataract extraction by phacoemulsification 3) Patients with IOL fixed in the capsule 4) Patients with a calculated lens dioptric power within the target range of the investigational IOL 5) Patients with an expected postoperative CDVA of 0.5 or better 6) Patients who are able to cooperate with the postoperative follow-up 7) Enrollment of patients with the following a) - i) conditions shall be carefully considered by investigators. a) Cornea endothelial disorder with the cell count less than 500 cells/mm2 b) Glaucoma c) Histories of uveitis d) Diabetic retinopathy e) Pseudoexfoliation syndrome f) High myopia g) Congenital ocular abnormalities h) Severe ciliary zonular dehiscenece i) With some problems in the capsular bag during the operation
Exclude criteria1) AMD or its precursor lesions 2) Histories of retinal detachment 3) Histories of vitreous surgery 4) Patient with active uveitis 5) Patients with iris neovascularization 6) Atopic cataract 7) Serious intraoperative complications 8) Meeting the inclusion criterion 7) and judged to be ineligible 9) Judged to be ineligible by investigators for the reason of other systemic or ophthalmic disease 10) In single eye status or already implanted with other IOL in one eye

Related Information

Contact

Public contact
Name Akiko Yagi
Address 6-3-201 Kurahara Miyakonojo Miyazaki Miyazaki Japan 885-0051
Telephone +81-986-25-6889
E-mail officeplusi2012@mbr.nifty.com
Affiliation Oculus Co.Ltd.
Scientific contact
Name Yosai Mori
Address 6-3 Kurahara Miyakonojo Miyazaki Miyazaki Japan 885-0051
Telephone +81-986-22-1441
E-mail yosai730@gmail.com
Affiliation Miyata Eye Hospital