CataractNCT02644720
Neural Compensation, Visual Function and Visual Quality After Monofocal or Multifocal Intraocular Lens Implantation
A study testing multifocal intraocular lens implantation, monofocal intraocular lens implantation and Dexamethasone in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cataract
- What is being tested?
- multifocal intraocular lens implantation, monofocal intraocular lens implantation and Dexamethasone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D., 8613802793086, haot.lin@hotmail.com
Jing Li, M.D., +86-20-87330341, Reviewborad_SYsU@163.com
About this study
Official title: Neural Compensation, Visual Function and Visual Quality in Senile Cataract Patients After Monofocal or Multifocal Intraocular Lens Implantation
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- multifocal intraocular lens implantation, monofocal intraocular lens implantation, Dexamethasone, multifocal intraocular lens (IOL) (Tecnis ZMB00), monofocal intraocular lens (IOL) (Tecnis ZCB)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifocal intraocular lens implantationProcedure or surgery
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.
monofocal intraocular lens implantationProcedure or surgery
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
DexamethasoneDrug
All patients received subconjunctival dexamethasone (2 mg) during surgery
multifocal intraocular lens (IOL) (Tecnis ZMB00)Device
monofocal intraocular lens (IOL) (Tecnis ZCB)Device
| Study group | Role | What they receive |
|---|---|---|
| multifocal intraocular lens group | Experimental | Not described Receives: Procedure: multifocal intraocular lens implantation; Drug: Dexamethasone; Device: multifocal intraocular lens (IOL) (Tecnis ZMB00) |
| monofocal intraocular lens group | Active comparator | Not described Receives: Procedure: monofocal intraocular lens implantation; Drug: Dexamethasone; Device: monofocal intraocular lens (IOL) (Tecnis ZCB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from contrast sensitivity
Contrast sensitivity (CS) was tested with a Contrast Glare Tester 1000
Measured: 1 week, 1 month, 3 month, 6 month,1 year after surgery
Change from functional magnetic resonance imaging
Measured: 1 week, 1 month, 3 month, 6 month,1 year after surgery
Secondary outcomes (1)
Change from best corrected visual acuity
Measured: 1 week, 1 month, 3 month, 6 month,1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2019 (estimated)
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Weirong Chen, M.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D.;Ph.D., Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityHaotian Lin, M.D.;Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644720
- Sponsor's protocol ID
- CCPMOH2010-China12
- Status last verified
- Dec 2015
- First submitted
- 27 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25880685Kalantzis 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.
PubMed 25138745Hayashi 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.
PubMed 11713071Kim 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.
PubMed 21700107Pieh 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.
PubMed 11423456Lin 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.
PubMed 29548900
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Compensation, Visual Function and Visual Quality in Senile Cataract Patients After Monofocal or Multifocal Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT02644720
- Acronym / sponsor ID
- CCPMOH2010-China12
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- Jan 2014
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multifocal intraocular lens implantationIn 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. | Procedure or surgery | multifocal intraocular lens group |
| monofocal intraocular lens implantationIn 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 | Procedure or surgery | monofocal intraocular lens group |
| DexamethasoneAll patients received subconjunctival dexamethasone (2 mg) during surgery | Drug | 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 |
Primary outcome
Change from contrast sensitivity
Time frame: 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
Time frame: 1 week, 1 month, 3 month, 6 month,1 year after surgery
1 secondary outcome
Change from best corrected visual acuity
Time frame: 1 week, 1 month, 3 month, 6 month,1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Background: PubMed 25880685Yao 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.
- Background: PubMed 25138745Kalantzis 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.
- Background: PubMed 11713071Hayashi 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.
- Background: PubMed 21700107Kim 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.
- Background: PubMed 11423456Pieh 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.
- Derived from this study: PubMed 29548900Lin 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.
- Description Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
Related trials for Cataract
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weirong Chen, M.D. study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D.;Ph.D. study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Haotian Lin, M.D.;Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multifocal intraocular lens implantation, monofocal intraocular lens implantation and Dexamethasone in people with Cataract, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haotian Lin, M.D.;Ph.D. (+8613802793086, haot.lin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from contrast sensitivity (time frame: 1 week, 1 month, 3 month, 6 month,1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02644720, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.