CataractNCT05594537
The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation
An observational study of Cataract and Near Vision, run by Yune Zhao.
Trial summary
The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cataract, Near Vision
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 Jan 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From December 2019 to present, cataract patients underwent phacoemulsification combined with ZXR00 IOLs or ZMB00 IOLs implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).
Who may be able to join
- Age of 18-80 years
- Cataract surgery is planned
- The operation was successful without any complications
- Implanted with ZXR00 IOLS or ZMB00 IOLs
Who cannot join
- The history of retinopathy or retinal surgery
- Irregular corneal astigmatism
- Regular corneal astigmatism of 1.00 diopter (D) or more
- Iris abnormalities
- Macular degeneration
- Neuro-ophthalmic disease
- The history of ocular inflammation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Best Way to Improve the Near Visual Acuity After Implantation of Tecnis Symfony® ZXR00 Intraocular Lens
The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation
Read the detailed description
ZXR00 intraocular lens is a new type of IOL that can achieve good continuous visual acuity. Its characteristic is to improve the distance and intermedia visual acuity and maintain good visual quality while sacrificing the near visual acuity. Previous studies report that there are mainly two ways to improve the near visual acuity of ZXR00：1.Bilateral implantation of ZXR00 with micromonovision. 2. Combined Implantation of ZXR00 and multifocal IOLs.This study aim to explore which is the best way to improve the near visual acuity after ZXR00 IOL implantation.
- Conditions
- Cataract, Near Vision
- Medical subject headings
- Cataract, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ZXR00+ZXR00 emmetropia group | The bilateral implantation of ZXR00 IOLs，and emmetropia was considered as the target refraction for both eyes. | |
| ZXR00+ZXR00 micromonovision group | The bilateral implantation of ZXR00 IOLs，and the ZXR00 IOLs power calculations were performed using a micro-monovision approach aiming for minimal residual myopia (≈ -0.50 D) in the nondominant eye and emmetropia in the dominant eye. | |
| ZXR00ZMB00 group | The blended implantation of bifocal IOLs (ZMB00) and ZXR IOLs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuities
Uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).
Measured: 2022.12.31
Corrected Visual Acuities
Corrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).
Measured: 2022.12.31
Defocus Curve
Corrected monocular and binocular defocus curves were measured from +2.5 D to -4.0 D (in 0.5 D steps).
Measured: 2022.12.31
Patient satisfaction
Patient satisfaction was rated on a scale of 1 to 5: 1 = very dissatisfied; 2 = dissatisfied; 3 = neutral; 4 = satisfied; and 5 = very satisfied.
Measured: 2022.12.31
Subjective quality of vision
Subjective quality of vision was evaluated using the 14-item Visual Function Questionnaire (VFQ-14).Each item was scaled according to the degree of difficulty of different activities: 4 points (no difficulty), 3 points (a little difficulty), 2 points (a moderate amount of difficulty), 1 point (a great deal of difficulty), and 0 point (unable to do the activity).overall score is range 0-56.The higher the score, the worse subjective quality of vision.
Measured: 2022.12.31
Adverse visual symptoms
Adverse visual symptoms including blurred vision, glare, starbursts, haloes, hazy vision, distortion, focusing diffculties, multiple images, and depth perception diffculty, was evaluated using the Quality of Vision test. This test includes 30 items, with a score between 0 and 3 (overall score range 0-90).The higher the score, the more postoperative adverse visual symptoms.
Measured: 2022.12.31
Stereopsis
Stereopsis was evaluated using OCULUS Binoptometer.
Measured: 2022.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yune Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, Study director, Ophthalmology and Optometry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594537
- Sponsor's protocol ID
- ZXR00-zyy
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Best Way to Improve the Near Visual Acuity After Implantation of Tecnis Symfony® ZXR00 Intraocular Lens
- ClinicalTrials.gov ID
- NCT05594537
- Acronym / sponsor ID
- ZXR00-zyy
- Conditions
- Cataract, Near Vision
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 26 Oct 2022 (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.
The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation
Detailed description
ZXR00 intraocular lens is a new type of IOL that can achieve good continuous visual acuity. Its characteristic is to improve the distance and intermedia visual acuity and maintain good visual quality while sacrificing the near visual acuity. Previous studies report that there are mainly two ways to improve the near visual acuity of ZXR00：1.Bilateral implantation of ZXR00 with micromonovision. 2. Combined Implantation of ZXR00 and multifocal IOLs.This study aim to explore which is the best way to improve the near visual acuity after ZXR00 IOL implantation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZXR00+ZXR00 emmetropia group | – | –The bilateral implantation of ZXR00 IOLs，and emmetropia was considered as the target refraction for both eyes. |
| ZXR00+ZXR00 micromonovision group | – | –The bilateral implantation of ZXR00 IOLs，and the ZXR00 IOLs power calculations were performed using a micro-monovision approach aiming for minimal residual myopia (≈ -0.50 D) in the nondominant eye and emmetropia in the dominant eye. |
| ZXR00ZMB00 group | – | –The blended implantation of bifocal IOLs (ZMB00) and ZXR IOLs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From December 2019 to present, cataract patients underwent phacoemulsification combined with ZXR00 IOLs or ZMB00 IOLs implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).
Key inclusion criteria (4 listed)
- Age of 18-80 years
- Cataract surgery is planned
- The operation was successful without any complications
- Implanted with ZXR00 IOLS or ZMB00 IOLs
Key exclusion criteria (7 listed)
- The history of retinopathy or retinal surgery
- Irregular corneal astigmatism
- Regular corneal astigmatism of 1.00 diopter (D) or more
- Iris abnormalities
- Macular degeneration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uncorrected Visual Acuities
Time frame: 2022.12.31
Uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).
Corrected Visual Acuities
Time frame: 2022.12.31
Corrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).
Defocus Curve
Time frame: 2022.12.31
Corrected monocular and binocular defocus curves were measured from +2.5 D to -4.0 D (in 0.5 D steps).
Patient satisfaction
Time frame: 2022.12.31
Patient satisfaction was rated on a scale of 1 to 5: 1 = very dissatisfied; 2 = dissatisfied; 3 = neutral; 4 = satisfied; and 5 = very satisfied.
Subjective quality of vision
Time frame: 2022.12.31
Subjective quality of vision was evaluated using the 14-item Visual Function Questionnaire (VFQ-14).Each item was scaled according to the degree of difficulty of different activities: 4 points (no difficulty), 3 points (a little difficulty), 2 points (a moderate amount of difficulty), 1 point (a great deal of difficulty), and 0 point (unable to do the activity).overall score is range 0-56.The higher the score, the worse subjective quality of vision.
Adverse visual symptoms
Time frame: 2022.12.31
Adverse visual symptoms including blurred vision, glare, starbursts, haloes, hazy vision, distortion, focusing diffculties, multiple images, and depth perception diffculty, was evaluated using the Quality of Vision test. This test includes 30 items, with a score between 0 and 3 (overall score range 0-90).The higher the score, the more postoperative adverse visual symptoms.
Stereopsis
Time frame: 2022.12.31
Stereopsis was evaluated using OCULUS Binoptometer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
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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.
Yune Zhao study director
Ophthalmology and Optometry Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Near Vision, run by Yune Zhao.
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 7 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Yune Zhao (8613819707056, zyehzeye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Visual Acuities (time frame: 2022.12.31). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2022.