Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

Zhejiang University

Status: Unknown

Conditions: Subluxation of Lens; Surgical Instruments，Cataract

Treatments: Device: Multifunctional Cataract-assisted Retractor

Study type: Interventional

Funder types: Other

Identifiers

NCT04062084

xuwen2017-034

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Multifunctional Cataract-assisted Retractor

Experimental group

Description:

Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor

Treatment:

Device: Multifunctional Cataract-assisted Retractor

Capsule Retractor

Experimental group

Description:

Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor

Treatment:

Device: Multifunctional Cataract-assisted Retractor