Neural Compensation, Visual Function and Visual Quality After Monofocal or Multifocal Intraocular Lens Implantation

Not Applicable

• Conditions: Cataract
• Interventions: Procedure: multifocal intraocular lens implantation; Procedure: monofocal intraocular lens implantation; Drug: Dexamethasone; Device: multifocal intraocular lens (IOL) (Tecnis ZMB00); Device: monofocal intraocular lens (IOL) (Tecnis ZCB)

• Registration Number: NCT02644720
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they can bring about halos and glare, which are caused by design deficiencies of the IOLs. Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may increase the difficulty of neural compensation reconstruction in patients with multifocal intraocular lens implantation. Patients enrolled into the study will be followed for 1 year and will have study visits preoperatively, at 1 week, 3 months, 6 months, 12 months postoperatively.In this trial, we aimed to specify the time of neural compensation reconstruction in patients and to explore the changes of visual function in senile patients with monofocal or multifocal intraocular lens implantation.

Detailed Description

Cataract extraction and intraocular lens (IOL) implantation are the current standard treatments for age-related cataract (ARC). Cataract surgery increases visual acuity but may lead to complaints after surgery. Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they can bring about halos and glare, which are caused by design deficiencies of the IOLs. Fortunately, most of the halos and glare diminish with time. Niels et al noted that neural adaptation (NA) may explain the lower incidence of glare and halos in their study. Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may increase the difficulty of neural compensation reconstruction in patients with multifocal intraocular lens implantation.

In the present study, the investigators evaluated the activity of neurons in the visual cortex using fMRI both preoperatively and postoperatively. In addition, the investigators evaluated postoperative changes in VF, including visual acuity (VA), contrast sensitivity (CS), straylight values (SVs), and pattern visual evoked potential (PVEP), stereoscopic vision, wavefront aberrations at 1 week, 3 months, 6 months, 12 months postoperatively.In this trial, the investigators aimed to specify the time of neural compensation reconstruction in patients and to explore the changes of visual function in senile patients with monofocal or multifocal intraocular lens implantation.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2015-12
• Study First Submitted: 2015-12-27
• Study First Submitted QC: 2015-12-31
• Last Update Submitted: 2015-12-31
• Study First Posted: 2016-01-01
• Last Update Posted: 2016-01-01
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• visual acuity less than 0.3
• Cataracts in both eyes classified by the Lens Opacity Classification System III
• Corneal astigmatism less than 1.5 diopters (D)
• Capability of understanding and signing the informed consent

Exclusion Criteria

• Corneal astigmatism ≥ 1.5D.
• History of neurological or psychiatric disorders; systemic disease such as severe hypertension or diabetes mellitus that might interfere with the visual outcomes.
• Associated ocular disease that could interfere with final results
• Previous anterior and posterior segment surgery and intraoperative or postoperative complications
• Driving at night frequently; excessive expectations for visual outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multifocal intraocular lens group	multifocal intraocular lens implantation	-
multifocal intraocular lens group	multifocal intraocular lens (IOL) (Tecnis ZMB00)	-
monofocal intraocular lens group	monofocal intraocular lens implantation	-
monofocal intraocular lens group	monofocal intraocular lens (IOL) (Tecnis ZCB)	-
monofocal intraocular lens group	Dexamethasone	-
multifocal intraocular lens group	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Change from functional magnetic resonance imaging	1 week, 1 month, 3 month, 6 month,1 year after surgery
Change from contrast sensitivity	1 week, 1 month, 3 month, 6 month,1 year after surgery	Contrast sensitivity (CS) was tested with a Contrast Glare Tester 1000

Secondary Outcome Measures

Name	Time	Method
Change from best corrected visual acuity	1 week, 1 month, 3 month, 6 month,1 year after surgery

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China