Evaluation of Cataract Surgery Outcome

Sponsor

Evidence Based Cataract Study Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT02182921

Collaborator

(none)

20,000

Enrollment

Location

136

Duration (Months)

147

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract High Myopia

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of Surgical Outcomes of Cataract Surgery

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Change from baseline in intraocular light scattering at six months after cataract surgery [Follow-up until six months after surgery]

Other Outcome Measures

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

Criteria

Ages Eligible for Study:

N/A to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Clinical diagnosis of mental illness
Mentally disabled

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye and ENT Hospital of Fudan University	Shanghai	Shanghai	China	200031

Sponsors and Collaborators

Evidence Based Cataract Study Group

Investigators

Study Chair: Yi Lu, MD, Eye and ENT Hospital of Fudan University
Study Director: Xiangjia Zhu, MD, Eye and ENT Hospital of Fudan University
Study Director: Jin Yang, MD, Eye and ENT Hospital of Fudan University
Principal Investigator: Keke Zhang, MD, Eye and ENT Hospital of Fudan University
Principal Investigator: Wenwen He, MD, Eye and ENT Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

xiangjiazhu, MD, Evidence Based Cataract Study Group

ClinicalTrials.gov Identifier:

NCT02182921

Other Study ID Numbers:

NSFC/YOUNG-81100653

First Posted:

Jul 8, 2014

Last Update Posted:

Aug 20, 2021

Last Verified:

Aug 1, 2021

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Aug 20, 2021