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 |
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Health condition(s) or Problem(s) studied | Cataract |
Date of first enrollment | 18/06/2020 |
Target sample size | 278 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | The incidence of wet-AMD for 3 years after surgery |
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Secondary Outcome | 1) 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 |
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Age maximum | <= 75age old |
Gender | Both |
Include criteria | 1) 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 criteria | 1) 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
Primary Sponsor | Mori Yosai |
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Secondary Sponsor | |
Source(s) of Monetary Support | HOYA CORPORATION |
Secondary ID(s) |
Contact
Public contact | |
Name | Akiko Yagi |
Address | 6-3-210 Kurahara Miyakonojo Miyazaki Miyazaki Japan 885-0051 |
Telephone | +81-986-25-6889 |
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 |
yosai730@gmail.com | |
Affiliation | Miyata Eye Hospital |