Intraocular LensNCT04557579
Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation
An observational study of Intraocular Lens, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
Trial summary
To compare the visual performance of the extended depth of focus (EDOF) intraocular lens (IOL) to bifocal and spherical monofocal IOL Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Intraocular Lens
- What is being tested?
- Clear corneal phacoemulsification and IOL implantation
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Dec 2018to 22 Jan 2020
- Phase
- Observational
- 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
Study population: This study was conducted from 2018 to 2020 in the Taipei Nobel Eye Clinic and Universal Eye Center ophthalmology clinic. The research protocol was explained to all prospective participants, after which they provided written informed consent before participating. The study was approved by the Ethics Committee of Chunghua Christian Hospital, and the protocol accorded with the tenets of the Declaration of Helsinki.
Who may be able to join
- presence of cataract in both eyes
- age between 50 and 80 years
- CDVA of both eyes under 20/40
- Phacoemulsification cataract surgery was arranged for both eyes
Who cannot join
- complicated cataract
- corneal opacities or irregularities
- corneal astigmatism > 1.5 diopter
- dry eye (Schirmer's test I ≤ 5mm)
- amblyopia
- anisometropia
Show all 14Show fewer
- surgical complications such as posterior capsular bag rupture or vitreous loss
- IOL tilt or decentration
- coexisting ocular pathologies
- glaucoma
- non-dilating pupil
- history of intraocular surgery, laser therapy, or retinopathy
- optic nerve or macular diseases
- refusal or unable to maintain follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the visual performance of the extended depth of focus (EDOF) intraocular lens (IOL) to bifocal and spherical monofocal IOL
Read the detailed description
This study was conducted from 2018 to 2020. This study included patients who were with presence of cataract in both eyes, age between 50 and 80 years, and corrected distance visual acuity (CDVA) of both eyes under 20/40. Phacoemulsification cataract surgery was arranged for both eyes for all patients. The study groups of IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA). The patients were routinely examined preoperatively as well as 1 month after surgery for far and near visual acuity (in LogMAR unit). Contrast sensitivity, wavefront aberration and quality of vision questionnaire was measured at the 1-month postoperative visit. These aforementioned outcomes were recorded and compared between groups.
- Conditions
- Intraocular Lens
- Being tested
- Clear corneal phacoemulsification and IOL implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear corneal phacoemulsification and IOL implantationProcedure or surgery
Clear corneal phacoemulsification and IOL implantation were performed by 2 surgeons (Chao-Kai Chang and Hung-Yuan Lin) by using an identical technique to minimize differences in surgically induced aberrations between groups. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA).
| Study group | Role | What they receive |
|---|---|---|
| Bifocal group | Patients in bifocal group implanted with Restor +2.5D IOL (Alcon, Fort Worth, TX, USA) in bilateral eyes Receives: Procedure: Clear corneal phacoemulsification and IOL implantation | |
| Extended depth of focus group | Patients in extended depth of focus group implanted with EDOF Symfony IOL (AMO, Santa Ana, CA, USA) in bilateral eyes Receives: Procedure: Clear corneal phacoemulsification and IOL implantation | |
| Monofocal group | Patients in monofocal group implanted with Sensar AR40e IOL (AMO, Santa Ana, CA, USA) in bilateral eyes Receives: Procedure: Clear corneal phacoemulsification and IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ophthalmic examinations
far uncorrected visual acuity(UCVA) and corrected distance visual acuity (CDVA), near UCVA in LogMAR unit
Measured: 1 month after surgery.
Wavefront examination
Wavefront analysis was performed only at the 1-month postoperative visit with an AMO WaveScan Hartmann-Shack sensor (Santa Clara, CA, USA). The wavefront maps were analyzed using a 6-mm pupil diameter and a Zernike polynomial expansion up to the sixth-order of Zernike coefficients. Higher order aberrations including RMS errors of horizontal coma aberration (Z 3,1), spherical aberration (4,0), trefoil aberration and the higher order aberrations were assessed.
Measured: at the 1-month postoperative visit
Contrast sensitivity
CS was also measured at the 1-month postoperative visit using the Vector Vision CSV-1000 (Greenville, OH, USA) chart. All subjects were tested at the recommended distance of 8 feet. The CSV-1000 consists of a series of circular achromatic sine-wave patches having a 1.5-in. diameter and comprising 4 rows, each corresponding to one of 4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd). We selected 3, 6 and 12 cpd for analysis.
Measured: at the 1-month postoperative visit
Questionnaire
Subjective QoV was evaluated using a questionnaire adopted from a near-activity 19-item questionnaire and the NEI-RQL-42. Our questionnaire contains 11 questions and the subscales include far vision, diurnal fluctuation, glare and halos, spectacle dependence, near vision, and intermediate vision. In general, questionnaires were completed without assistance; however, on the patient's request, explanations of the questions were provided.
Measured: at the 1-month postoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start24 Dec 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
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 Intraocular LensStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Nobel Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Kai Chang, Taipei Nobel Eye Clinic
- Investigators
- Chao-Kai Chang, Ph.D., Principal investigator, Taipei Nobel Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557579
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
PubMed 22972061Kohnen T, Nuijts R, Levy P, Haefliger E, Alfonso JF. Visual function after bilateral implantation of apodized diffractive aspheric multifocal intraocular lenses with a +3.0 D addition. J Cataract Refract Surg. 2009 Dec;35(12):2062-9. doi: 10.1016/j.jcrs.2009.08.013.
PubMed 19969209Thibos LN, Ye M, Zhang X, Bradley A. The chromatic eye: a new reduced-eye model of ocular chromatic aberration in humans. Appl Opt. 1992 Jul 1;31(19):3594-600. doi: 10.1364/AO.31.003594.
PubMed 20725330Perez-Merino P, Dorronsoro C, Llorente L, Duran S, Jimenez-Alfaro I, Marcos S. In vivo chromatic aberration in eyes implanted with intraocular lenses. Invest Ophthalmol Vis Sci. 2013 Apr 12;54(4):2654-61. doi: 10.1167/iovs.13-11912.
PubMed 23493299Weeber HA, Piers PA. Theoretical performance of intraocular lenses correcting both spherical and chromatic aberration. J Refract Surg. 2012 Jan;28(1):48-52. doi: 10.3928/1081597X-20111103-01. Epub 2011 Nov 10.
PubMed 22074466Denoyer A, Le Lez ML, Majzoub S, Pisella PJ. Quality of vision after cataract surgery after Tecnis Z9000 intraocular lens implantation: effect of contrast sensitivity and wavefront aberration improvements on the quality of daily vision. J Cataract Refract Surg. 2007 Feb;33(2):210-6. doi: 10.1016/j.jcrs.2006.10.035.
PubMed 17276260
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT04557579
- Acronym / sponsor ID
- 001
- Conditions
- Intraocular Lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Taipei Nobel Eye ClinicUniversity, hospital or other
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 21 Sep 2020 (actual)
- 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.
To compare the visual performance of the extended depth of focus (EDOF) intraocular lens (IOL) to bifocal and spherical monofocal IOL
Detailed description
This study was conducted from 2018 to 2020. This study included patients who were with presence of cataract in both eyes, age between 50 and 80 years, and corrected distance visual acuity (CDVA) of both eyes under 20/40. Phacoemulsification cataract surgery was arranged for both eyes for all patients. The study groups of IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA). The patients were routinely examined preoperatively as well as 1 month after surgery for far and near visual acuity (in LogMAR unit). Contrast sensitivity, wavefront aberration and quality of vision questionnaire was measured at the 1-month postoperative visit. These aforementioned outcomes were recorded and compared between groups.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bifocal group | – | Procedure: Clear corneal phacoemulsification and IOL implantationPatients in bifocal group implanted with Restor +2.5D IOL (Alcon, Fort Worth, TX, USA) in bilateral eyes |
| Extended depth of focus group | – | Procedure: Clear corneal phacoemulsification and IOL implantationPatients in extended depth of focus group implanted with EDOF Symfony IOL (AMO, Santa Ana, CA, USA) in bilateral eyes |
| Monofocal group | – | Procedure: Clear corneal phacoemulsification and IOL implantationPatients in monofocal group implanted with Sensar AR40e IOL (AMO, Santa Ana, CA, USA) in bilateral eyes |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was conducted from 2018 to 2020 in the Taipei Nobel Eye Clinic and Universal Eye Center ophthalmology clinic. The research protocol was explained to all prospective participants, after which they provided written informed consent before participating. The study was approved by the Ethics Committee of Chunghua Christian Hospital, and the protocol accorded with the tenets of the Declaration of Helsinki.
Key inclusion criteria (4 listed)
- presence of cataract in both eyes
- age between 50 and 80 years
- CDVA of both eyes under 20/40
- Phacoemulsification cataract surgery was arranged for both eyes
Key exclusion criteria (14 listed)
- complicated cataract
- corneal opacities or irregularities
- corneal astigmatism > 1.5 diopter
- dry eye (Schirmer's test I ≤ 5mm)
- amblyopia
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 |
|---|---|---|
| Clear corneal phacoemulsification and IOL implantationClear corneal phacoemulsification and IOL implantation were performed by 2 surgeons (Chao-Kai Chang and Hung-Yuan Lin) by using an identical technique to minimize differences in surgically induced aberrations between groups. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA). | Procedure or surgery | Bifocal group, Extended depth of focus group, Monofocal group |
Primary outcome
Ophthalmic examinations
Time frame: 1 month after surgery.
far uncorrected visual acuity(UCVA) and corrected distance visual acuity (CDVA), near UCVA in LogMAR unit
Wavefront examination
Time frame: at the 1-month postoperative visit
Wavefront analysis was performed only at the 1-month postoperative visit with an AMO WaveScan Hartmann-Shack sensor (Santa Clara, CA, USA). The wavefront maps were analyzed using a 6-mm pupil diameter and a Zernike polynomial expansion up to the sixth-order of Zernike coefficients. Higher order aberrations including RMS errors of horizontal coma aberration (Z 3,1), spherical aberration (4,0), trefoil aberration and the higher order aberrations were assessed.
Contrast sensitivity
Time frame: at the 1-month postoperative visit
CS was also measured at the 1-month postoperative visit using the Vector Vision CSV-1000 (Greenville, OH, USA) chart. All subjects were tested at the recommended distance of 8 feet. The CSV-1000 consists of a series of circular achromatic sine-wave patches having a 1.5-in. diameter and comprising 4 rows, each corresponding to one of 4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd). We selected 3, 6 and 12 cpd for analysis.
Questionnaire
Time frame: at the 1-month postoperative visit
Subjective QoV was evaluated using a questionnaire adopted from a near-activity 19-item questionnaire and the NEI-RQL-42. Our questionnaire contains 11 questions and the subscales include far vision, diurnal fluctuation, glare and halos, spectacle dependence, near vision, and intermediate vision. In general, questionnaires were completed without assistance; however, on the patient's request, explanations of the questions were provided.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 22972061Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
- Background: PubMed 19969209Kohnen T, Nuijts R, Levy P, Haefliger E, Alfonso JF. Visual function after bilateral implantation of apodized diffractive aspheric multifocal intraocular lenses with a +3.0 D addition. J Cataract Refract Surg. 2009 Dec;35(12):2062-9. doi: 10.1016/j.jcrs.2009.08.013.
- Background: PubMed 20725330Thibos LN, Ye M, Zhang X, Bradley A. The chromatic eye: a new reduced-eye model of ocular chromatic aberration in humans. Appl Opt. 1992 Jul 1;31(19):3594-600. doi: 10.1364/AO.31.003594.
- Background: PubMed 23493299Perez-Merino P, Dorronsoro C, Llorente L, Duran S, Jimenez-Alfaro I, Marcos S. In vivo chromatic aberration in eyes implanted with intraocular lenses. Invest Ophthalmol Vis Sci. 2013 Apr 12;54(4):2654-61. doi: 10.1167/iovs.13-11912.
- Background: PubMed 22074466Weeber HA, Piers PA. Theoretical performance of intraocular lenses correcting both spherical and chromatic aberration. J Refract Surg. 2012 Jan;28(1):48-52. doi: 10.3928/1081597X-20111103-01. Epub 2011 Nov 10.
- Background: PubMed 17276260Denoyer A, Le Lez ML, Majzoub S, Pisella PJ. Quality of vision after cataract surgery after Tecnis Z9000 intraocular lens implantation: effect of contrast sensitivity and wavefront aberration improvements on the quality of daily vision. J Cataract Refract Surg. 2007 Feb;33(2):210-6. doi: 10.1016/j.jcrs.2006.10.035.
- Individual participant dataSharing planned: No
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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.
Chao-Kai Chang, Ph.D. principal investigator
Taipei Nobel Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Lens, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
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 14 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: finished, as of the sponsor's last update on 21 Sep 2020. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ophthalmic examinations (time frame: 1 month after surgery.). The study lists 4 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 NCT04557579, 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 21 Sep 2020.