Cataract Cataract
Conditions
Interventions
Group A: Implantation of a intraocular lens with blue light blocking
Group B: Implantation of a intraocular lens without blue light blocking
Sponsors
Mori Yosai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of wet-AMD for 3 years after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Compare the incidence of wet AMD precursor lesions or 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. | — |
Contacts
Public ContactAkiko Yagi
Oculus Co.Ltd.
Outcome results
None listed