Evaluation of Cataract Surgery Outcome

Cataract Clinical Trial

Official title:

Evaluation of Surgical Outcomes of Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02182921
• Other study ID #: NSFC/YOUNG-81100653
• Status: Recruiting
• Start date: August 2013
• Est. completion date: December 2030

Study information

• Verified date: February 2023
• Source: Evidence Based Cataract Study Group
• Contact: Yi Lu, MD
• Phone: (86)021-64377134
• Email: luyieent[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2030
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of cataract

• Must be able to cooperate with the ophthalmic examination

Exclusion Criteria:

• Clinical diagnosis of mental illness

• Mentally disabled

Related Conditions & MeSH terms

• Cataract
• High Myopia

Locations

Country	Name	City	State
China	Eye and ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Evidence Based Cataract Study Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The difference between attempted and achieved refractive correction at one month after cataract surgery		Follow-up until one month after surgery
Other	The difference between attempted and achieved refractive correction at six months after cataract surgery		Follow-up until six months after surgery
Primary	Change from baseline in visual acuity at one month after cataract surgery		Follow-up until one month after surgery
Primary	Change from baseline in spherical equivalent at one month after cataract surgery		Follow-up until one month after surgery
Primary	Change from baseline in visual acuity at six months after cataract surgery		Follow-up until six months after surgery
Primary	Change from baseline in spherical equivalent at six months after cataract surgery		Follow-up until six months after cataract surgery
Secondary	Change from baseline in wavefront aberration at one month after cataract surgery		Follow-up until one month after surgery
Secondary	Change from baseline in contrast sensitivity at one month after cataract surgery		Follow-up until one month after surgery
Secondary	Change from baseline in intraocular light scattering at one month after cataract surgery		Follow-up until one month after surgery
Secondary	Change from baseline in wavefront aberration at six months after cataract surgery		Follow-up until six months after surgery
Secondary	Change from baseline in contrast sensitivity at six months after cataract surgery		Follow-up until six months after surgery
Secondary	Change from baseline in intraocular light scattering at six months after cataract surgery		Follow-up until six months after surgery