Clinical outcomes in eyes with diffractive continuous range-of-vision intraocular lens

JRCT ID: jRCTs032210305

Registered date:13/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cataract
• Date of first enrollment: 08/10/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Implantation of extended depth of focus intraocular lens or trifocal IOLs bilaterally during surgery of bilateral cataract patients

Outcome(s)

Primary Outcome

Examine differences in binocular distance-corrected visual acuity at 30 cm and 40 cm of eyes with extended depth-of-focus or trifocal IOLs 3 months after implantation.
Examine differences in severity of dysphoric phenomena between eyes with extended depth-of-focus and trifocal IOLs 3 months after implantation.

Secondary Outcome

- Examine differences in binocular contrast sensitivity at distance 2.5m and near 1 m, 40 cm

- Others: product deficiencies than primary and secondary outcomes

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study:
1) Patients who will undergo bilateral cataract surgery and are eligible for multifocal IOL implantation in both eyes.
2) Patients aged from 60 to 79 years.
3) Patients whose postoperative refractions are intended for emmetropia.

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study.
1) Patients with other ocular disease influencing visual function, such as uveitis, acute ocular disease, external/internal infection, diabetic retinopathy, glaucoma, exfoliation syndrome, pathological miosis, keratoconus, corneal endothelial dystrophy, and weak zonule.
2) Patients with history of intraocular or corneal surgery
3) Patients with other systemic or ophthalmic diseases considered to be unsuitable by an investigator.

Related Information

• Primary Sponsor: Bissen Hiroko
• Source(s) of Monetary Support: AMO Japan Ltd