NCT03584139

Brief Summary

Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after PPV. Intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported. The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are currently popular for cataract in vitrectomized eyes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

May 21, 2018

Last Update Submit

March 5, 2020

Conditions

CataractVitrectomy

Outcome Measures

Primary Outcomes (3)

  • Stability of anterior chamber and pupil

    The traditional phacoemulsification in vitrectomized eyes usually with more Intraoperative difficulties such as abnormal anterior chamber deepening and unstable pupil. To evaluate whether the new method will increase the stability of anterior chamber and pupil.

    Intraoperative

  • Time of operation

    To evaluate whether the new method will shorten the operation time

    Intraoperative

  • Cumulative dissipated energy (CDE)

    To evaluate whether the new method will decrease CDE. CDE reflect the damage of phacoemulsification to the eye, It can be acquired automatically from the phacoemulsification machine. The unit of CDE is mJ.

    Intraoperative

Secondary Outcomes (4)

  • The presence of intraoperative complications

    Intraoperative

  • Visual acuity (VA)

    3 months after opreation

  • Intraocular pressure(IOP)

    3 months after opreation

  • The presence of postoperative complications

    3 months after opreation

Study Arms (2)

IRIS HOOK

EXPERIMENTAL

iris hook assisted maneuver in phacoemulsification

Device: IRIS HOOK

TRADITION

ACTIVE COMPARATOR

traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation

Device: TRADITION

Interventions

IRIS HOOKDEVICE

iris hook assisted maneuver in phacoemulsification

IRIS HOOK
TRADITIONDEVICE

traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation

TRADITION

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with visually significant cataract following PPV
  • After PPV vitreous substitutes were air / gas (Perfluoropropane:C3F8) or BSS,
  • After PPV if vitreous substitute was silicone oil, that should be removed at least 3 months.
  • The duration between PPV / silicone oil remove and phacoemulsification should more than 3 months
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

You may not qualify if:

  • Eyes with a history of acute angle-closure glaucoma, trauma,
  • Eyes with a clinically dislocated or subluxated lens.
  • Active ocular or periocular infection in the study eye
  • Uncontrolled Blood Pressure
  • Pregnant or breast-feeding women
  • Participation in another simultaneous medical investigator or trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Ling Bai, MD,PhD

    Second affiliated hospital of Xian Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

May 21, 2018

First Posted

July 12, 2018

Study Start

April 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)