Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2020-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03976791

Cataract

UNKNOWN NA

Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

NCT01429532

Cataract

COMPLETED

Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract

NCT04977115

Cataract Extraction

UNKNOWN NA

Effect of the Timing of Cataract Surgery on Complications in Patients With Bilateral Congenital Cataracts

NCT02581046

Cataract

COMPLETED NA

Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.

NCT03701139

Cataract Posterior Capsule Opacification

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery.

The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore，the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications.

In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

modified 2.2mm micoincision

Group Type EXPERIMENTAL

modified 2.2mm microincision

Intervention Type PROCEDURE

enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification

conventional 2.2mm microincision

Group Type ACTIVE_COMPARATOR

conventional 2.2mm microincision

Intervention Type PROCEDURE

conventional 2.2mm coaxial microincision phacoemulsification

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

modified 2.2mm microincision

enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification

Intervention Type PROCEDURE

conventional 2.2mm microincision

conventional 2.2mm coaxial microincision phacoemulsification

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged-related cataract patients between 65 and 90 years ;
* Lens nuclear opalescence grade ≥4.0 on the Lens Opacities Classification System III (LOCS III);
* Scheduled for phacoemulsification combined with intraocular lens implantation.
* The number of corneal endothelial cells \> 1500cells/mm2.
* Dilated pupil diameter ≥6mm

Exclusion Criteria

* A history of ophthalmic trauma or surgery;
* Other ophthalmic diseases such as glaucoma, uveitis, high myopia;
* Ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, etc.

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes