NCT04014699

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

July 6, 2019

Last Update Submit

September 13, 2020

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Incidence of DMD at postoperative day 1

    Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1

    postoperative day 1

Secondary Outcomes (6)

  • maximal incision thickness

    postoperative day 1, day 7, month 1, month 3

  • surgical induced-astigmatism

    postoperative day 1, day 7, month 1, month 3

  • the length of DMD

    postoperative day 1, day 7, month 1, month 3

  • Best corrected visual acuity (BCVA)

    postoperative day 1, day 7, month 1, month 3

  • modulation transfer function (MTF)-cut off

    postoperative day 1, day 7, month 1, month 3

  • +1 more secondary outcomes

Study Arms (2)

modified 2.2mm micoincision

EXPERIMENTAL
Procedure: modified 2.2mm microincision

conventional 2.2mm microincision

ACTIVE COMPARATOR
Procedure: conventional 2.2mm microincision

Interventions

modified 2.2mm microincisionPROCEDURE

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

modified 2.2mm micoincision
conventional 2.2mm microincisionPROCEDURE

conventional 2.2mm coaxial microincision phacoemulsification

conventional 2.2mm microincision

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, 510060, China

Location

Related Publications (1)

  • Dai Y, Liu Z, Wang W, Han X, Jin L, Chen X, Jin G, Wang L, Zhang E, Qu B, Liu J, Congdon N, He M, Luo L, Liu Y. Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Nov 1;139(11):1228-1234. doi: 10.1001/jamaophthalmol.2021.4148.

    PMID: 34647960DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Yizhi Liu, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2019

First Posted

July 10, 2019

Study Start

July 22, 2019

Primary Completion

October 22, 2019

Study Completion

January 22, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

CN(1)