Clinical trial NCT02182921: Evaluation of Cataract Surgery Outcome
Official title: Evaluation of Surgical Outcomes of Cataract Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
High Myopia
Lead sponsor: Evidence Based Cataract Study Group
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 20000
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical centre: Eye and ENT Hospital of Fudan University

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Clinical diagnosis of mental illness
* Mentally disabled

Primary outcomes:
measure: Change from baseline in visual acuity at one month after cataract surgery
timeFrame: Follow-up until one month after surgery
measure: Change from baseline in spherical equivalent at one month after cataract surgery
timeFrame: Follow-up until one month after surgery
measure: Change from baseline in visual acuity at six months after cataract surgery
timeFrame: Follow-up until six months after surgery
measure: Change from baseline in spherical equivalent at six months after cataract surgery
timeFrame: Follow-up until six months after cataract surgery
Secondary outcomes:
measure: Change from baseline in wavefront aberration at one month after cataract surgery
timeFrame: Follow-up until one month after surgery
measure: Change from baseline in contrast sensitivity at one month after cataract surgery
timeFrame: Follow-up until one month after surgery
measure: Change from baseline in intraocular light scattering at one month after cataract surgery
timeFrame: Follow-up until one month after surgery
measure: Change from baseline in wavefront aberration at six months after cataract surgery
timeFrame: Follow-up until six months after surgery
measure: Change from baseline in contrast sensitivity at six months after cataract surgery
timeFrame: Follow-up until six months after surgery
measure: Change from baseline in intraocular light scattering at six months after cataract surgery
timeFrame: Follow-up until six months after surgery
Other outcomes:
measure: The difference between attempted and achieved refractive correction at one month after cataract surgery
timeFrame: Follow-up until one month after surgery
measure: The difference between attempted and achieved refractive correction at six months after cataract surgery
timeFrame: Follow-up until six months after surgery
Locations:
city: Shanghai
country: China
facility: Eye and ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Yi Lu, MD
role: STUDY_CHAIR
affiliation: Eye and ENT Hospital of Fudan University
name: Xiangjia Zhu, MD
role: STUDY_DIRECTOR
affiliation: Eye and ENT Hospital of Fudan University
name: Jin Yang, MD
role: STUDY_DIRECTOR
affiliation: Eye and ENT Hospital of Fudan University
name: Keke Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Wenwen He, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.