Neural Compensation, Visual Function and Visual Quality After Monofocal or Multifocal Intraocular Lens Implantation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: multifocal intraocular lens group
|
Procedure: multifocal intraocular lens implantation
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.
Drug: Dexamethasone
All patients received subconjunctival dexamethasone (2 mg) during surgery
Device: multifocal intraocular lens (IOL) (Tecnis ZMB00)
|
| Active Comparator: monofocal intraocular lens group
|
Procedure: monofocal intraocular lens implantation
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
Drug: Dexamethasone
All patients received subconjunctival dexamethasone (2 mg) during surgery
Device: monofocal intraocular lens (IOL) (Tecnis ZCB)
|
Outcome Measures
Primary Outcome Measures
- 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
- Change from functional magnetic resonance imaging [1 week, 1 month, 3 month, 6 month,1 year after surgery]
Secondary Outcome Measures
- Change from best corrected visual acuity [1 week, 1 month, 3 month, 6 month,1 year after surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
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visual acuity less than 0.3
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Cataracts in both eyes classified by the Lens Opacity Classification System III
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Corneal astigmatism less than 1.5 diopters (D)
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Capability of understanding and signing the informed consent
Exclusion Criteria:
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Corneal astigmatism ≥ 1.5D.
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History of neurological or psychiatric disorders; systemic disease such as severe hypertension or diabetes mellitus that might interfere with the visual outcomes.
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Associated ocular disease that could interfere with final results
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Previous anterior and posterior segment surgery and intraoperative or postoperative complications
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Driving at night frequently; excessive expectations for visual outcomes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhognshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
- First Affiliated Hospital, Sun Yat-Sen University
Investigators
- Study Director: Weirong Chen, M.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study Chair: Yizhi Liu, M.D.;Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
- Principal Investigator: Haotian Lin, M.D.;Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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. Review.
- 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.
- Pieh S, Lackner B, Hanselmayer G, Zöhrer 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.
- 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.
- CCPMOH2010-China12