Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multifocal intraocular lens group | Experimental |
| |
| monofocal intraocular lens group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multifocal intraocular lens implantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from contrast sensitivity | Contrast sensitivity (CS) was tested with a Contrast Glare Tester 1000 | 1 week, 1 month, 3 month, 6 month,1 year after surgery |
| Change from functional magnetic resonance imaging | 1 week, 1 month, 3 month, 6 month,1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from best corrected visual acuity | 1 week, 1 month, 3 month, 6 month,1 year after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haotian Lin, M.D.;Ph.D. | Contact | +8613802793086 | haot.lin@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Weirong Chen, M.D. | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Director |
| Yizhi Liu, M.D.;Ph.D. | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhognshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25880685 | Background | 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. | |
| 25138745 | Background |
| Label | URL |
|---|---|
| Description Home page of Zhongshan Ophthalmic Center | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| monofocal intraocular lens implantation | Procedure | 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 |
|
| Dexamethasone | Drug | All patients received subconjunctival dexamethasone (2 mg) during surgery |
|
| multifocal intraocular lens (IOL) (Tecnis ZMB00) | Device |
|
| monofocal intraocular lens (IOL) (Tecnis ZCB) | Device |
|
| Haotian Lin, M.D.;Ph.D. |
| Zhongshan Ophthalmic Center, Sun Yat-sen University |
| Principal Investigator |
| 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. |
| 11713071 | Background | 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. |
| 21700107 | Background | 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. |
| 11423456 | Background | 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. |
| 29548900 | Derived | 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. |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000075542 | Multifocal Intraocular Lenses |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007910 | Lenses, Intraocular |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
Not provided
Not provided