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
About this trial
This is an interventional treatment trial for Cataract
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
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
NCT ID
NCT03584139
First Posted
May 21, 2018
Last Updated
March 5, 2020
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
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
Learn more about this trial
IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
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