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Status unknownNCT03976791Updated Jun 14, 2019

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

An interventional study of enlarged internal incision and regular 2.2mm incision in Cataract, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 65 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-14.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
294
Allocation
Randomized
Ages
65 Years to 90 Years
Sex
All
01

Study 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

02

Conditions studied

  • Cataract
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 294 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
294 participants (estimated)

Study arms

  • Experimental
    Enlarged internal incision

    enlarged the internal incision about 0.4mm

    Procedure: enlarged internal incision

  • Placebo comparator
    Regular 2.2mm incision

    regular 2.2mm corneal incision for microincision coaxial phacoemulsification

    Procedure: regular 2.2mm incision

Interventions

  • Procedureenlarged internal incision

    enlarging the internal incision about 0.4mm

  • Procedureregular 2.2mm incision

    2.2mm microincision coaxial phacoemulsification

06

What researchers measure

Primary outcomes

  1. descemet membrane detachment(DMD)

    DMD at the incision observed by anterior segment optical coherence tomography

    Time frame: postoperative 1 week

07

Study locations

1 site
  • Zhongshan Ophthalmic Center
    Guangzhou, Guangdong 510060, China
    • Yizhi Liu, Doctor · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03976791
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Sponsor
First posted
Jun 6, 2019
Start date
Jul 1, 2019 (estimated)
Primary completion
Nov 1, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
Jun 14, 2019

Study contacts

Yizhi Liu, Doctor
Contact
liuyizh@mail.sysu.edu.cn
87330475
Yizhi Liu, Doctor
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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