Dry EyeNCT02234635
Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens After Cataract Surgery
A study testing Diffractive multifocal IOLs group in people with Dry Eye and Vision Disorders, run by Wenzhou Medical University at 1 site in China.
Trial summary
In this study, the investigators examined the subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Dry Eye, Vision Disorders, Quality of Life
- What is being tested?
- Diffractive multifocal IOLs group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Feb 2015
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eyes with an axial length of 22.00 to 25.00 mm with age-related cataract.
Who cannot join
- Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation.
- Patients who could not be available for follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Fang, Yu, 13758452287, 357574103@qq.com
About this study
Official title: Phase 1 Evaluate the Visual Quality Change of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses; Phase 2 Evaluate the Tear Film Quality Dynamics of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses.
In this study, the investigators examined the subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS value (OV),and the tear-film quality dynamics including the tear break-up time and the tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality analysis system (OQAS).
Read the detailed description
50 eyes of 50 cataract patients scheduled for phacoemulsification surgery were recruited, the multifocal group (25 eyes) ，were implantation with Tecnis® ZMB00；and the monofocal group (25 eyes) were implantation with Tecnis® ZCB00.
Methods: All eyes were examined by logMAR visual acuity chart and Optical quality analysis system (OQAS) at 1 week, 1 month, 3 month, 6 month,12 month after surgery for the subjective and objective visual quality Change during the first year.
Measures:Subjective and objective visual quality were evaluated.Tear-film quality dynamicswere evaluated.
- Conditions
- Dry Eye, Vision Disorders, Quality of Life
- Being tested
- Diffractive multifocal IOLs group
- Keywords
- visual acuity, objective visual quality, multifocal intraocular lens, tear-film quality dynamics
- Medical subject headings
- Dry Eye Syndromes, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffractive multifocal IOLs groupOther
Diffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| monofocal IOLs group | Other | monofocal IOLs group were implantation with Tecnis® ZCB00 Receives: Other: Diffractive multifocal IOLs group |
| Diffractive multifocal IOLs group | Active comparator | Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00 Receives: Other: Diffractive multifocal IOLs group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens
Visual quality change during the first year after cataract surgery. The visual quality including the subjective and objective visual quality. The subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) and distance corrected near visual acuity (DCNVA).
The objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI) and OQAS value (OV).
Measured: 1week, 1month, 3month,6month,12month
Secondary outcomes (1)
To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens
The tear-film quality dynamics including the tear break-up time and the tear-film OSI were examined by optical quality analysis system (OQAS)
Measured: 1week, 1month, 3month,6month,12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2012
- Primary completionSep 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
- Investigators
- Fang Yu, Study director, Affiliated Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234635
- Sponsor's protocol ID
- VQIOL-21
- Status last verified
- Sep 2014
- First submitted
- 31 Jul 2014
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ye L, Chen T, Hu Z, Yang Q, Su Q, Li J. Comparison of the visual performance between Oculentis MF30 and Tecnis ZMB00 multifocal intraocular lenses. Ann Transl Med. 2021 Jan;9(2):144. doi: 10.21037/atm-20-7777.
PubMed 33569446Chen T, Yu F, Lin H, Zhao Y, Chang P, Lin L, Chen Q, Zheng Q, Zhao YE, Lu F, Li J. Objective and subjective visual quality after implantation of all optic zone diffractive multifocal intraocular lenses: a prospective, case-control observational study. Br J Ophthalmol. 2016 Nov;100(11):1530-1535. doi: 10.1136/bjophthalmol-2015-307135. Epub 2016 Feb 22.
PubMed 26903522
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluate the Visual Quality Change of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses; Phase 2 Evaluate the Tear Film Quality Dynamics of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses.
- ClinicalTrials.gov ID
- NCT02234635
- Acronym / sponsor ID
- VQIOL-21
- Conditions
- Dry Eye, Vision Disorders, Quality of Life
- Keywords
- visual acuity, objective visual quality, multifocal intraocular lens, tear-film quality dynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 9 Sep 2014 (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.
In this study, the investigators examined the subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS value (OV),and the tear-film quality dynamics including the tear break-up time and the tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality analysis system (OQAS).
Detailed description
50 eyes of 50 cataract patients scheduled for phacoemulsification surgery were recruited, the multifocal group (25 eyes) ，were implantation with Tecnis® ZMB00；and the monofocal group (25 eyes) were implantation with Tecnis® ZCB00.
Methods: All eyes were examined by logMAR visual acuity chart and Optical quality analysis system (OQAS) at 1 week, 1 month, 3 month, 6 month,12 month after surgery for the subjective and objective visual quality Change during the first year.
Measures:Subjective and objective visual quality were evaluated.Tear-film quality dynamicswere evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monofocal IOLs group | Other | Other: Diffractive multifocal IOLs groupmonofocal IOLs group were implantation with Tecnis® ZCB00 |
| Diffractive multifocal IOLs group | Active comparator | Other: Diffractive multifocal IOLs groupDiffractive multifocal IOLs group were implantation with Tecnis® ZMB00 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes with an axial length of 22.00 to 25.00 mm with age-related cataract.
Key exclusion criteria (2 listed)
- Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation.
- Patients who could not be available for follow-up.
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 |
|---|---|---|
| Diffractive multifocal IOLs groupDiffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity. | Other | Diffractive multifocal IOLs group, monofocal IOLs group |
Primary outcome
To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens
Time frame: 1week, 1month, 3month,6month,12month
Visual quality change during the first year after cataract surgery. The visual quality including the subjective and objective visual quality. The subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) and distance corrected near visual acuity (DCNVA). The objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI) and OQAS value (OV).
1 secondary outcome
To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens
Time frame: 1week, 1month, 3month,6month,12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
- Derived from this study: PubMed 33569446Ye L, Chen T, Hu Z, Yang Q, Su Q, Li J. Comparison of the visual performance between Oculentis MF30 and Tecnis ZMB00 multifocal intraocular lenses. Ann Transl Med. 2021 Jan;9(2):144. doi: 10.21037/atm-20-7777.
- Derived from this study: PubMed 26903522Chen T, Yu F, Lin H, Zhao Y, Chang P, Lin L, Chen Q, Zheng Q, Zhao YE, Lu F, Li J. Objective and subjective visual quality after implantation of all optic zone diffractive multifocal intraocular lenses: a prospective, case-control observational study. Br J Ophthalmol. 2016 Nov;100(11):1530-1535. doi: 10.1136/bjophthalmol-2015-307135. Epub 2016 Feb 22.
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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.
Fang Yu study director
Affiliated Eye Hospital of Wenzhou Medical 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 Diffractive multifocal IOLs group in people with Dry Eye and Vision Disorders, run by Wenzhou Medical 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 1 inclusion and 2 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 9 Sep 2014. 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 Fang Yu (13758452287, 357574103@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens (time frame: 1week, 1month, 3month,6month,12month). 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 NCT02234635, which also lists 2 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 9 Sep 2014.