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

Not Applicable

• Conditions: cataract; Ocular disease

• Registration Number: JPRN-jRCTs032210305
• Lead Sponsor: Bissen Hiroko

Brief Summary

This study was aimed to examine differences in binocular visual acuity and contrast sensitivity after implantation of continuous-focus IOLs (Synergy) with those with trifocal IOLs. Although the superiority in binocular visual acuities at 30 cm and 40 cm, and binocular contrast sensitivities at far, 1 m, and 40 cm were denied, clinical characteristic of subjective IOLs in uncorrected binocular visual acuity and symptoms of dysphotopsia were clarified.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-13
• Study Completion: 2022-08-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Examine differences in severity of dysphoric phenomena between eyes with extended depth-of-focus and trifocal IOLs 3 months after implantation.

Secondary Outcome Measures

Name	Time	Method
- Examine differences in binocular contrast sensitivity at distance 2.5m and near 1 m, 40 cm<br><br>- Others: product deficiencies than primary and secondary outcomes