Evaluation of Cataract Surgery Outcome

NCT02182921 | Recruiting

• 1 other identifier: NSFC/YOUNG-81100653
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract; High Myopia

Outcome Measures

Primary Outcomes (4)

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

  Follow-up until one month after surgery

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

  Follow-up until one month after surgery

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

  Follow-up until six months after surgery

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

  Follow-up until six months after cataract surgery

Secondary Outcomes (6)

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

  Follow-up until one month after surgery

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

  Follow-up until one month after surgery

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

  Follow-up until one month after surgery

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

  Follow-up until six months after surgery

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

  Follow-up until six months after surgery

Other Outcomes (2)

• The difference between attempted and achieved refractive correction at one month after cataract surgery

  Follow-up until one month after surgery

• The difference between attempted and achieved refractive correction at six months after cataract surgery

  Follow-up until six months after surgery

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Medical centre: Eye and ENT Hospital of Fudan University

You may qualify if:

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

You may not qualify if:

• Clinical diagnosis of mental illness
• Mentally disabled

Sponsors & Collaborators

• Evidence Based Cataract Study Group: lead

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 40835236 DERIVED

• 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.

  PMID: 40461064 DERIVED

• 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.

  PMID: 34675151 DERIVED

• 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.

  PMID: 34433780 DERIVED

• 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.

  PMID: 33249933 DERIVED

• 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.

  PMID: 32974413 DERIVED

• 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.

  PMID: 31704699 DERIVED

• 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.

  PMID: 26089212 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Yi Lu, MD

  Eye and ENT Hospital of Fudan University

  STUDY CHAIR

• Xiangjia Zhu, MD

  Eye and ENT Hospital of Fudan University

  STUDY DIRECTOR

• Jin Yang, MD

  Eye and ENT Hospital of Fudan University

  STUDY DIRECTOR

• Keke Zhang, MD

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Wenwen He, MD

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Lu, MD

CONTACT

(86)021-64377134; luyieent@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: July 8, 2014
• Study Start: August 1, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

CN (1)