Long-term stability of Clareon intraocular lens

JRCT ID: jRCTs032190093

Registered date:10/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Senile ( age related ) cataract
• Date of first enrollment: 10/09/2019
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Implantation of Clareon and control intraocular lens during surgery of senile cataract eyes

Outcome(s)

Primary Outcome

Exploratorily evaluate that the change in corrected visual acuity during postoperative 3 years will be non-inferior to eyes with cintrol intraocular lens.
In addition, whether no change in corrected visual acuity during the postoperrative period is examined.

Secondary Outcome

1.No decrease of contrast sensitivity.
2.Incidence and morphology of posterior capsule opacification quantitatively using a software such as ePCO from retro-illumination images after mydriasis
3.Rate of posterior capsulotomy
4.Incidence and degree of glistenings measured by slit-lap microscope observations based on grade classification definition and numbers of water aggregates
5.Surface scatterings measured densitometry analysis from Scheimpflug images with an anterior-segment analyzer Pentacam or Pentacam HR (Oculus) after mydriasis
6.Other product deficiencies than primary and secondary outcomes

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study
1) Patients scheduled for cataract surgery by phacoemulsification due to age related cataract
2) Patients in whom the intraocular lens is expected to be able to be inserted and fixed in crystalline lens capsule
3) Patients in whom the calculated lens power is within available range
4) Patients who do not have other eye diseases than cataract which affect postoperative outcomes
5) Patients in whom postoperative corrected visual acuities are expected to be 0.8 or higher
6) Patients who can be followed up after the operation
7) Patients aged 20 years or elder at giving their consent
8) Patients who can understand the content of informed consent documents and can provide written consent form
9) Male and female

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study.
1) Patients with eye diseases such as uncontrolled glaucoma,
progressive diabetic retinopathy, uveitis, retinal detachment, iris neovascularization, corneal degeneration, or patients with history of corneal surgery
2) Patients with eye diseases that may influence postoperative visual acuity, or p atients using medicines that may influence visual acuity
3) Patients who plan secondary implantation of intraocular lens
4) Patients who would require comp licated surgery due to zonular rupture, posterior capsule rapture, vitreous prolapse, hyphema, incompletion of in the bag implantation, etc.
5) Patients who have risks of serious postoperative complications
6) Patients with other physical body or ophthalmic dise ases considered unsuitable for participating in the study by an investigator.

Related Information

• Primary Sponsor: Miyata Akira
• Source(s) of Monetary Support: Alcon Japan Ltd