AzTrials
AzTrials

CataractNCT02182921

Evaluation of Cataract Surgery Outcome

An observational study of Cataract and High Myopia, run by Evidence Based Cataract Study Group at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the visual outcome of the cataract surgery, including best uncorrected and corrected visual acuity, spherical equivalent, wavefront aberration and other measurements. Read more about this study

Who is it for?
Ages Up to 90 years
Conditions the study is for
Cataract, High Myopia
How many people
20,000 participants
Where
1 siteChina
Study dates
Aug 2013to Dec 2030
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 Up to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Medical centre: Eye and ENT Hospital of Fudan University

Who may be able to join

  • Clinical diagnosis of cataract
  • Must be able to cooperate with the ophthalmic examination

Who cannot join

  • Clinical diagnosis of mental illness
  • Mentally disabled

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yi Lu, MD contact

(86)021-64377134

luyieent@163.com

China1 site, 1 recruiting

  • Eye and ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200031

    Yi Lu, MD, (86)021-64377134, luyieent@163.com

    Recruiting

Other trials in China

About this study

Official title: Evaluation of Surgical Outcomes of Cataract Surgery

The purpose of this study is to evaluate the visual outcome of the cataract surgery, including best uncorrected and corrected visual acuity, spherical equivalent, wavefront aberration and other measurements.

Medical subject headings
Cataract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in visual acuity at one month after cataract surgery

    Measured: Follow-up until one month after surgery

  2. Change from baseline in spherical equivalent at one month after cataract surgery

    Measured: Follow-up until one month after surgery

  3. Change from baseline in visual acuity at six months after cataract surgery

    Measured: Follow-up until six months after surgery

  4. Change from baseline in spherical equivalent at six months after cataract surgery

    Measured: Follow-up until six months after cataract surgery

Secondary outcomes (6)

  1. Change from baseline in wavefront aberration at one month after cataract surgery

    Measured: Follow-up until one month after surgery

  2. Change from baseline in contrast sensitivity at one month after cataract surgery

    Measured: Follow-up until one month after surgery

  3. Change from baseline in intraocular light scattering at one month after cataract surgery

    Measured: Follow-up until one month after surgery

  4. Change from baseline in wavefront aberration at six months after cataract surgery

    Measured: Follow-up until six months after surgery

  5. Change from baseline in contrast sensitivity at six months after cataract surgery

    Measured: Follow-up until six months after surgery

  6. Change from baseline in intraocular light scattering at six months after cataract surgery

    Measured: Follow-up until six months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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-control
Time perspective
Prospective
Enrolment
20,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182921
Sponsor's protocol ID
NSFC/YOUNG-81100653
Status last verified
Aug 2024
First submitted
24 Jun 2014
Last updated
28 Aug 2024
Results posted
No

Publications

  • Zhou J, Chen Y, Meng J, Cheng K, Qi J, Du Y, Yao Y, Lu Y, He W, Zhu X. Comparative analysis of iris blood flow after first-eye and second-eye cataract surgeries: insights into increased pain perception in the second eye. BMJ Open Ophthalmol. 2025 Aug 19;10(1):e002162. doi: 10.1136/bmjophth-2025-002162.

    PubMed 40835236

  • Chen C, Zhou J, Cheng K, Hu X, Zhu M, Du Y, Meng J, Lu Y, He W, Zhu X. Lens position change following cataract surgery in eyes with thick lenses: an SS-OCT based study. Br J Ophthalmol. 2025 Sep 23;109(10):1120-1125. doi: 10.1136/bjo-2025-327414.

    PubMed 40461064

  • Yao Y, Meng J, He W, Zhang K, Wei L, Cheng K, Lu Y, Zhu X. Associations between anterior segment parameters and rotational stability of a plate-haptic toric intraocular lens. J Cataract Refract Surg. 2021 Nov 1;47(11):1436-1440. doi: 10.1097/j.jcrs.0000000000000653.

    PubMed 34675151

  • Lu Q, Wei L, He W, Zhang K, Wang J, Zhang Y, Rong X, Zhao Z, Cai L, He X, Wu J, Ding D, Lu Y, Zhu X. Lens Opacities Classification System III-based artificial intelligence program for automatic cataract grading. J Cataract Refract Surg. 2022 May 1;48(5):528-534. doi: 10.1097/j.jcrs.0000000000000790.

    PubMed 34433780

  • Zhu X, Lu Q, Yao Y, Xu X, Lu Y. Intraoperative Pain Sensation During Cataract Surgery: Why Does Timing Matter? Curr Eye Res. 2021 Jul;46(7):971-977. doi: 10.1080/02713683.2020.1857776. Epub 2020 Dec 15.

    PubMed 33249933

  • Lu Q, He W, Lu Y, Zhu X. Morphological features of anterior segment: factors influencing intraocular pressure after cataract surgery in nanophthalmos. Eye Vis (Lond). 2020 Sep 9;7:47. doi: 10.1186/s40662-020-00212-4. eCollection 2020.

    PubMed 32974413

  • Zhu X, Qi J, He W, Zhang S, Zhang K, Lu Q, Lu Y. Early transient intraocular pressure spike after cataract surgery in highly myopic cataract eyes and associated risk factors. Br J Ophthalmol. 2020 Aug;104(8):1137-1141. doi: 10.1136/bjophthalmol-2019-315117. Epub 2019 Nov 8.

    PubMed 31704699

  • Zhu X, He W, Zhang K, Lu Y. Factors influencing 1-year rotational stability of AcrySof Toric intraocular lenses. Br J Ophthalmol. 2016 Feb;100(2):263-8. doi: 10.1136/bjophthalmol-2015-306656. Epub 2015 Jun 18.

    PubMed 26089212

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and High Myopia, run by Evidence Based Cataract Study Group 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 2 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: looking for participants now, as of the sponsor's last update on 28 Aug 2024. 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 Yi Lu, MD ((86)021-64377134, luyieent@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in visual acuity at one month after cataract surgery (time frame: Follow-up until one 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 NCT02182921, which also lists 8 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 28 Aug 2024.

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