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IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

Primary Purpose

Cataract, Vitrectomy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IRIS HOOK
TRADITION
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IRIS HOOK

TRADITION

Arm Description

iris hook assisted maneuver in phacoemulsification

traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation

Outcomes

Primary Outcome Measures

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.
Time of operation
To evaluate whether the new method will shorten the operation time
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.

Secondary Outcome Measures

The presence of intraoperative complications
The incidence of complications, including infusion deprivation syndrome, anterior capsulorhexis extension, iris trauma, descemets detachment, posterior capsular defect, nucleus drop, etc
Visual acuity (VA)
To evaluate whether the surgery can effectively increase VA.
Intraocular pressure(IOP)
The traditional phacoemulsification in vitrectomized eyes usually cause low IOP in the early stage, and sometimes induce detachment of choroid. To evaluate whether the new method will avoid the low IOP in the early stage.
The presence of postoperative complications
The incidence of complications, including corneal edema, cystoid macular edema, etc.

Full Information

First Posted
May 21, 2018
Last Updated
March 5, 2020
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03584139
Brief Title
IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
Official Title
IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
With the continuous evolution in vitrectomy techniques and instrumentation, an increasing number of vitreorential disorders are being successfully managed with pars plana vitrectomy (PPV). Cataract is one of the most common complications seen in phakic patients following PPV, and the incidence of it ranges from 4 to 80%, even up to 100% in various studies. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IRIS HOOK
Arm Type
Experimental
Arm Description
iris hook assisted maneuver in phacoemulsification
Arm Title
TRADITION
Arm Type
Active Comparator
Arm Description
traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
Intervention Type
Device
Intervention Name(s)
IRIS HOOK
Intervention Description
iris hook assisted maneuver in phacoemulsification
Intervention Type
Device
Intervention Name(s)
TRADITION
Intervention Description
traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
Primary Outcome Measure Information:
Title
Stability of anterior chamber and pupil
Description
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.
Time Frame
Intraoperative
Title
Time of operation
Description
To evaluate whether the new method will shorten the operation time
Time Frame
Intraoperative
Title
Cumulative dissipated energy (CDE)
Description
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.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
The presence of intraoperative complications
Description
The incidence of complications, including infusion deprivation syndrome, anterior capsulorhexis extension, iris trauma, descemets detachment, posterior capsular defect, nucleus drop, etc
Time Frame
Intraoperative
Title
Visual acuity (VA)
Description
To evaluate whether the surgery can effectively increase VA.
Time Frame
3 months after opreation
Title
Intraocular pressure(IOP)
Description
The traditional phacoemulsification in vitrectomized eyes usually cause low IOP in the early stage, and sometimes induce detachment of choroid. To evaluate whether the new method will avoid the low IOP in the early stage.
Time Frame
3 months after opreation
Title
The presence of postoperative complications
Description
The incidence of complications, including corneal edema, cystoid macular edema, etc.
Time Frame
3 months after opreation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Bai, MD,PhD
Organizational Affiliation
Second affiliated hospital of Xian Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

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