Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

Subluxation of Lens Clinical Trial

Official title:

Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04062084
• Other study ID #: xuwen2017-034
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of lens subluxation.

• Patients need to undergo lens subluxation surgery

Exclusion Criteria:

• Active intraocular inflammation

• The intraocular pressure (IOP) was higher than 25 mmHg

• The endothelial cell count (ECC) was less than 1,200 cells/mm2

• Combined with other eye diseases

• Combined with other serious systemic diseases

Related Conditions & MeSH terms

• Cataract
• Lens Subluxation
• Subluxation of Lens
• Surgical Instruments,Cataract

Intervention

Device:
• Multifunctional Cataract-assisted Retractor
Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical success rate	Surgical success rate of operation with different retractor	through study completion, an average of 1 year
Secondary	Successful implantation rate of intraocular lens	implantation rate of intraocular lens with different retractor	through study completion, an average of 1 year
Secondary	Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart	1day postoperation,1 week,1 month, 3month postoperation
Secondary	intraocular pressure	intraocular pressure	1 day, 1 week, 1 month, and 3 month postoperation
Secondary	endothelial cell count	endothelial cell count	1 week, 1 month, and 3 month postoperation