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

JRCT ID: jRCTs072190056

Registered date:27/03/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 18/06/2020
• Target sample size: 278
• 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

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
• 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
• Source(s) of Monetary Support: HOYA CORPORATION