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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03976791

Enrollment

294

Registered

2019-06-06

Start date

2019-07-01

Completion date

2019-12-30

Last updated

2019-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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

Interventions

PROCEDUREenlarged internal incision

enlarging the internal incision about 0.4mm

PROCEDUREregular 2.2mm incision

2.2mm microincision coaxial phacoemulsification

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
descemet membrane detachment(DMD)	postoperative 1 week	DMD at the incision observed by anterior segment optical coherence tomography

Countries

China

Contacts

Primary ContactYizhi Liu, Doctor

liuyizh@mail.sysu.edu.cn87330475

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026