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

NCT02644720 | Unknown DMC

• 1 other identifier: CCPMOH2010-China12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change from best corrected visual acuity

  1 week, 1 month, 3 month, 6 month,1 year after surgery

Study Arms (2)

multifocal intraocular lens group

EXPERIMENTAL

Procedure: multifocal intraocular lens implantation; Drug: Dexamethasone; Device: multifocal intraocular lens (IOL) (Tecnis ZMB00)

monofocal intraocular lens group

ACTIVE COMPARATOR

Procedure: monofocal intraocular lens implantation; Drug: Dexamethasone; Device: monofocal intraocular lens (IOL) (Tecnis ZCB)

Interventions

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.

multifocal intraocular lens group

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

monofocal intraocular lens group

Dexamethasone DRUG

All patients received subconjunctival dexamethasone (2 mg) during surgery

monofocal intraocular lens group; multifocal intraocular lens group

multifocal intraocular lens (IOL) (Tecnis ZMB00) DEVICE

multifocal intraocular lens group

monofocal intraocular lens (IOL) (Tecnis ZCB) DEVICE

monofocal intraocular lens group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 25880685 BACKGROUND

• 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.

  PMID: 25138745 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.

  PMID: 11713071 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.

  PMID: 21700107 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.

  PMID: 11423456 BACKGROUND

• 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.

  PMID: 29548900 DERIVED

Related Links

• Description Home page of Zhongshan Ophthalmic Center

MeSH Terms

Conditions

Cataract

Interventions

Dexamethasone; Multifocal Intraocular Lenses

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Lenses, Intraocular; Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Officials

• 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

• Haotian Lin, M.D.;Ph.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haotian Lin, M.D.;Ph.D.

CONTACT

+8613802793086; haot.lin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: December 27, 2015
• First Posted: January 1, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

CN (1)