A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

Sun Yat-sen University

Status: Unknown

Conditions: Cataract

Treatments: Procedure: enlarged internal incision; Procedure: regular 2.2mm incision

Study type: Interventional

Funder types: Other

Identifiers

NCT03976791

2019KYPJ078

Details and patient eligibility

About

Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.

The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.

Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.

Study Design: A prospective randomized controlled study

Enrollment: 294 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age-related cataract patients
• Age from 65 to 90
• The diameter of pupil after mydriasis is more than 6 mm
• LOCS III nuclear grade ≥4
• Corneal endothelial cell count > 1500 cells/mm2
• Phacoemulsification and intraocular lens implantation are planned
• Agree to participate in this study and sign informed consent

Exclusion criteria

• History of ocular trauma
• Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
• Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
• History of Ophthalmic Surgery
• Intraoperative and Postoperative Complications

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 2 patient groups, including a placebo group

Enlarged internal incision

Experimental group

Description:

enlarged the internal incision about 0.4mm

Treatment:

Procedure: enlarged internal incision

Regular 2.2mm incision

Placebo Comparator group

Description:

regular 2.2mm corneal incision for microincision coaxial phacoemulsification

Treatment:

Procedure: regular 2.2mm incision