Visual Acuity After the Combined Binocular Implantation of +2.5 Diopters and +3.0 Diopters ReSTOR Multifocal Intraocular Lenses.

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

• Registration Number: NCT02314572
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.5 D and +3.0 D apodized diffractive multifocal intraocular lenses.

Detailed Description

Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-11
• Study Completion: 2015-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• clinically significant cataract
• endothelial cell count: patients aged 18-75 years: > 1000 cells/mm2; patients > 75 years: > 750 cells/mm2
• absence of vision-limiting corneal or retinal comorbidities
• capability to understand the informed consent

Exclusion Criteria

• expected postoperative astigmatism > 0.75 diopters
• irregular astigmatism
• dilated pupil diameter < 3 mm
• corneal and fundus abnormalities that might cause visual impairments
• inability to attend follow-up visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm	Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses	-

Primary Outcome Measures

Name	Time	Method
Visual acuities in the far, intermediate and near	3 months	Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).
Mesopic vision	3 months	Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.
Scotopic contrast sensitivity	3 months	Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

Secondary Outcome Measures

Name	Time	Method
Spectacle independence in the far, intermediate and near	3 months	Spectacle independence as stated by the patient.

Trial Locations

Locations (1)

Charité - University Medicine Berlin, Department of Ophthalmology; 🇩🇪 Berlin, Germany