IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
NCT ID: NCT03584139
Last Updated: 2020-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2018-04-01
2019-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IRIS HOOK
iris hook assisted maneuver in phacoemulsification
IRIS HOOK
iris hook assisted maneuver in phacoemulsification
TRADITION
traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
TRADITION
traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
Interventions
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IRIS HOOK
iris hook assisted maneuver in phacoemulsification
TRADITION
traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
80 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Responsible Party
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Bai Ling
Associated Professor
Principal Investigators
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Ling Bai, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Second affiliated hospital of Xian Jiaotong University
Locations
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Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Countries
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Other Identifiers
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IRIS hook
Identifier Type: -
Identifier Source: org_study_id
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