Recruitment of ParticipantsNCT04833491
Study of the Correlation Between Preoperative Precise Biometrics, Spatial Assessment and Postoperative Visual Quality in Cataract Patients
An observational study of Recruitment of Participants, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intend to further improve the quality of Clinical Cataract diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 2 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Recruitment of Participants
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University
Who may be able to join
- Patients with monocular or binocular cataract, lens opacity or abnormal position, need surgery
Who cannot join
- The history of systemic diseases and medication affecting vision, diabetic patients with systemic conditions complicated with retinopathy, uncontrolled blood glucose, severe eye diseases, eye trauma, eye surgery, severe dry eye and ocular surface diseases, strabismus and amblyopia were identified
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Wen Xu
About this study
This study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intend to further improve the quality of Clinical Cataract diagnosis and treatment.
Read the detailed description
Based on the existing cataract surgery methods, through prospective follow-up study, this study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intends to further improve the quality of Clinical Cataract diagnosis and treatment.
- Conditions
- Recruitment of Participants
- Keywords
- refractive cataract surgery, intraocular lens
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 |
|---|---|---|
| Senile cataract | Not described | |
| Traumatic cataract | Not described | |
| Congenital cataract | Not described | |
| Lens dislocation group | Not described | |
| Complicated cataract | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
The BCVA was measured by the same optometrist at each visit
Measured: 1 week postoperatively
Best Corrected Visual Acuity
The BCVA was measured by the same optometrist at each visit
Measured: 1 month postoperatively
Best Corrected Visual Acuity
The BCVA was measured by the same optometrist at each visit
Measured: 3 months postoperatively
Uncorrected distance visual acuity
The UCVA was measured by the same optometrist at each visit
Measured: 1 week postoperatively
Uncorrected distance visual acuity
The UCVA was measured by the same optometrist at each visit
Measured: 1 month postoperatively
Uncorrected distance visual acuity
The UCVA was measured by the same optometrist at each visit
Measured: 3 months postoperatively
Intraocular pressure
Intraocular pressure measured using non-contact tonometer
Measured: 1 week postoperatively
Intraocular pressure
Intraocular pressure measured using non-contact tonometer
Measured: 1 month postoperatively
Intraocular pressure
Intraocular pressure measured using non-contact tonometer
Measured: 3 months postoperatively
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Measured: 1 week postoperatively
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Measured: 1 month postoperatively
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Measured: 3 months postoperatively
Endothelial cell density
Endothelial cell density was measured by specular microscopy
Measured: 1 month postoperatively
Contrast sensitivity
The contrast sensitivity was recorded in dark environment, glare dark environment, light environment, glare light environment
Measured: 1 month postoperatively
Defocusing curve
From +2.00d to -4.00d, 13 different diopter states were obtained by decreasing the spherical lens degree of +0.50d, and the defocus curve was formed
Measured: 1 month postoperatively
Stereoscopic vision
The binocular diopter was not corrected. The stereopsis test card was used to record the arc seconds of random points, animals and circles
Measured: 1 month postoperatively
Glasses usage frequency
The frequency of long / medium / short distance use of corrective glasses was scored as 0%, 25%, 50%, 75% and 100%
Measured: 3 months postoperatively
Optical visual quality questionnaire
Glare, halos, starburst and other visual quality problems were graded as mild（1 score), moderate（2 score) and severe（3 score)
Measured: 3 months postoperatively
Visual satisfaction
The visual acuity satisfaction of distance / middle / near distance was scored from 0 (totally dissatisfied) to 10 (totally satisfied)
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start20 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Recruitment of ParticipantsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833491
- Sponsor's protocol ID
- xuwen2021-0189
- Status last verified
- Mar 2021
- First submitted
- 2 Apr 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fang J, Shi C, Ma X, Sheng S, Xu J, Zhu S, Feng Y, Zhang Y, Liu L, Zhao H, Xu Z, Xu W. Anterior segment characteristics and spatial variations of different crystalline lens diseases. Photodiagnosis Photodyn Ther. 2025 Aug;54:104693. doi: 10.1016/j.pdpdt.2025.104693. Epub 2025 Jun 26.
PubMed 40581199Xu Z, Wang J, Shi C, Ni S, Xu J, Zhu S, Fang J, Xu W. Clinical outcomes of plate-haptic diffractive multifocal toric IOL in cataract eyes with long axial length and corneal astigmatism. Sci Rep. 2025 Apr 7;15(1):11881. doi: 10.1038/s41598-025-97040-0.
PubMed 40195538
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Correlation Between Preoperative Precise Biometrics, Spatial Assessment and Postoperative Visual Quality in Cataract Patients
- ClinicalTrials.gov ID
- NCT04833491
- Acronym / sponsor ID
- xuwen2021-0189
- Conditions
- Recruitment of Participants
- Keywords
- refractive cataract surgery, intraocular lens
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Apr 2021 (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.
This study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intend to further improve the quality of Clinical Cataract diagnosis and treatment.
Detailed description
Based on the existing cataract surgery methods, through prospective follow-up study, this study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intends to further improve the quality of Clinical Cataract diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Senile cataract | – | – |
| Traumatic cataract | – | – |
| Congenital cataract | – | – |
| Lens dislocation group | – | – |
| Complicated cataract | – | – |
Who may qualify
- Ages
- 2 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University
Key inclusion criteria (1 listed)
- Patients with monocular or binocular cataract, lens opacity or abnormal position, need surgery
Key exclusion criteria (1 listed)
- The history of systemic diseases and medication affecting vision, diabetic patients with systemic conditions complicated with retinopathy, uncontrolled blood glucose, severe eye diseases, eye trauma, eye surgery, severe dry eye and ocular surface diseases, strabismus and amblyopia were identified
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
Best Corrected Visual Acuity
Time frame: 1 week postoperatively
The BCVA was measured by the same optometrist at each visit
Best Corrected Visual Acuity
Time frame: 1 month postoperatively
The BCVA was measured by the same optometrist at each visit
Best Corrected Visual Acuity
Time frame: 3 months postoperatively
The BCVA was measured by the same optometrist at each visit
Uncorrected distance visual acuity
Time frame: 1 week postoperatively
The UCVA was measured by the same optometrist at each visit
Uncorrected distance visual acuity
Time frame: 1 month postoperatively
The UCVA was measured by the same optometrist at each visit
Uncorrected distance visual acuity
Time frame: 3 months postoperatively
The UCVA was measured by the same optometrist at each visit
Intraocular pressure
Time frame: 1 week postoperatively
Intraocular pressure measured using non-contact tonometer
Intraocular pressure
Time frame: 1 month postoperatively
Intraocular pressure measured using non-contact tonometer
Intraocular pressure
Time frame: 3 months postoperatively
Intraocular pressure measured using non-contact tonometer
Tear Breakup Time
Time frame: 1 week postoperatively
Tear Breakup Time was performed to assess tear film stability
Tear Breakup Time
Time frame: 1 month postoperatively
Tear Breakup Time was performed to assess tear film stability
Tear Breakup Time
Time frame: 3 months postoperatively
Tear Breakup Time was performed to assess tear film stability
Endothelial cell density
Time frame: 1 month postoperatively
Endothelial cell density was measured by specular microscopy
Contrast sensitivity
Time frame: 1 month postoperatively
The contrast sensitivity was recorded in dark environment, glare dark environment, light environment, glare light environment
Defocusing curve
Time frame: 1 month postoperatively
From +2.00d to -4.00d, 13 different diopter states were obtained by decreasing the spherical lens degree of +0.50d, and the defocus curve was formed
Stereoscopic vision
Time frame: 1 month postoperatively
The binocular diopter was not corrected. The stereopsis test card was used to record the arc seconds of random points, animals and circles
Glasses usage frequency
Time frame: 3 months postoperatively
The frequency of long / medium / short distance use of corrective glasses was scored as 0%, 25%, 50%, 75% and 100%
Optical visual quality questionnaire
Time frame: 3 months postoperatively
Glare, halos, starburst and other visual quality problems were graded as mild（1 score), moderate（2 score) and severe（3 score)
Visual satisfaction
Time frame: 3 months postoperatively
The visual acuity satisfaction of distance / middle / near distance was scored from 0 (totally dissatisfied) to 10 (totally satisfied)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 40581199Fang J, Shi C, Ma X, Sheng S, Xu J, Zhu S, Feng Y, Zhang Y, Liu L, Zhao H, Xu Z, Xu W. Anterior segment characteristics and spatial variations of different crystalline lens diseases. Photodiagnosis Photodyn Ther. 2025 Aug;54:104693. doi: 10.1016/j.pdpdt.2025.104693. Epub 2025 Jun 26.
- Derived from this study: PubMed 40195538Xu Z, Wang J, Shi C, Ni S, Xu J, Zhu S, Fang J, Xu W. Clinical outcomes of plate-haptic diffractive multifocal toric IOL in cataract eyes with long axial length and corneal astigmatism. Sci Rep. 2025 Apr 7;15(1):11881. doi: 10.1038/s41598-025-97040-0.
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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.
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 Recruitment of Participants, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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: looking for participants now, as of the sponsor's last update on 10 May 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Xu (+86-13858185223, xuwen2003@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 1 week postoperatively). The study lists 19 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 NCT04833491, 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 10 May 2021.