Neural Compensation, Visual Function and Visual Quality After Monofocal or Multifocal Intraocular Lens Implantation
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multifocal intraocular lens implantation
monofocal intraocular lens implantation
Dexamethasone
multifocal intraocular lens (IOL) (Tecnis ZMB00)
monofocal intraocular lens (IOL) (Tecnis ZCB)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
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
Sites / Locations
- Zhognshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
multifocal intraocular lens group
monofocal intraocular lens group
Arm Description
Outcomes
Primary Outcome Measures
Change from contrast sensitivity
Contrast sensitivity (CS) was tested with a Contrast Glare Tester 1000
Change from functional magnetic resonance imaging
Secondary Outcome Measures
Change from best corrected visual acuity
Full Information
NCT ID
NCT02644720
First Posted
December 27, 2015
Last Updated
December 31, 2015
Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02644720
Brief Title
Neural Compensation, Visual Function and Visual Quality After Monofocal or Multifocal Intraocular Lens Implantation
Official Title
Neural Compensation, Visual Function and Visual Quality in Senile Cataract Patients After Monofocal or Multifocal Intraocular Lens Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
multifocal intraocular lens group
Arm Type
Experimental
Arm Title
monofocal intraocular lens group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
multifocal intraocular lens implantation
Intervention Description
In this group, the surgery was performed with cataract extraction and multifocal intraocular lens (IOL) (Tecnis ZMB00). The standard technique in all patients consisted of sutureless phacomulsifacation using the Legacy 2000 Series and Infinity phacoemulsification machine (Alcon Laboratories Inc., Fort Worth, Texas, USA), with clear corneal incisions up to 3.2 mm and 5.0 to 5.5 mm capsulorhexis. Surgery in the fellow eye was performed 1 month later in each patient.
Intervention Type
Procedure
Intervention Name(s)
monofocal intraocular lens implantation
Intervention Description
In the group, the surgery was performed with cataract extraction and monofocal intraocular lens (IOL) (Tecnis ZCB). The surgery technique was same as the multifocal intraocular lens group
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
All patients received subconjunctival dexamethasone (2 mg) during surgery
Intervention Type
Device
Intervention Name(s)
multifocal intraocular lens (IOL) (Tecnis ZMB00)
Intervention Type
Device
Intervention Name(s)
monofocal intraocular lens (IOL) (Tecnis ZCB)
Primary Outcome Measure Information:
Title
Change from contrast sensitivity
Description
Contrast sensitivity (CS) was tested with a Contrast Glare Tester 1000
Time Frame
1 week, 1 month, 3 month, 6 month,1 year after surgery
Title
Change from functional magnetic resonance imaging
Time Frame
1 week, 1 month, 3 month, 6 month,1 year after surgery
Secondary Outcome Measure Information:
Title
Change from best corrected visual acuity
Time Frame
1 week, 1 month, 3 month, 6 month,1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haotian Lin, M.D.;Ph.D.
Phone
+8613802793086
Email
haot.lin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weirong Chen, M.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D.;Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D.;Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D., Ph.D.
Phone
8613802793086
Email
haot.lin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jing Li, M.D.
Phone
+86-20-87330341
Email
Reviewborad_SYsU@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
25880685
Citation
Yao K, Bao Y, Ye J, Lu Y, Bi H, Tang X, Zhao Y, Zhang J, Yang J. Efficacy of 1% carboxymethylcellulose sodium for treating dry eye after phacoemulsification: results from a multicenter, open-label, randomized, controlled study. BMC Ophthalmol. 2015 Mar 20;15:28. doi: 10.1186/s12886-015-0005-3.
Results Reference
background
PubMed Identifier
25138745
Citation
Kalantzis G, Papaconstantinou D, Karagiannis D, Koutsandrea C, Stavropoulou D, Georgalas I. Post-cataract surgery diplopia: aetiology, management and prevention. Clin Exp Optom. 2014 Sep;97(5):407-10. doi: 10.1111/cxo.12197.
Results Reference
background
PubMed Identifier
11713071
Citation
Hayashi K, Hayashi H, Nakao F, Hayashi F. Correlation between pupillary size and intraocular lens decentration and visual acuity of a zonal-progressive multifocal lens and a monofocal lens. Ophthalmology. 2001 Nov;108(11):2011-7. doi: 10.1016/s0161-6420(01)00756-4.
Results Reference
background
PubMed Identifier
21700107
Citation
Kim MJ, Zheleznyak L, Macrae S, Tchah H, Yoon G. Objective evaluation of through-focus optical performance of presbyopia-correcting intraocular lenses using an optical bench system. J Cataract Refract Surg. 2011 Jul;37(7):1305-12. doi: 10.1016/j.jcrs.2011.03.033.
Results Reference
background
PubMed Identifier
11423456
Citation
Pieh S, Lackner B, Hanselmayer G, Zohrer R, Sticker M, Weghaupt H, Fercher A, Skorpik C. Halo size under distance and near conditions in refractive multifocal intraocular lenses. Br J Ophthalmol. 2001 Jul;85(7):816-21. doi: 10.1136/bjo.85.7.816.
Results Reference
background
PubMed Identifier
29548900
Citation
Lin H, Zhang L, Lin D, Chen W, Zhu Y, Chen C, Chan KC, Liu Y, Chen W. Visual Restoration after Cataract Surgery Promotes Functional and Structural Brain Recovery. EBioMedicine. 2018 Apr;30:52-61. doi: 10.1016/j.ebiom.2018.03.002. Epub 2018 Mar 7.
Results Reference
derived
Links:
URL
http://www.gzzoc.com/
Description
Description Home page of Zhongshan Ophthalmic Center
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Neural Compensation, Visual Function and Visual Quality After Monofocal or Multifocal Intraocular Lens Implantation
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