IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IRIS HOOK iris hook assisted maneuver in phacoemulsification |
Device: IRIS HOOK
iris hook assisted maneuver in phacoemulsification
|
| Active Comparator: TRADITION traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation |
Device: TRADITION
traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
|
Outcome Measures
Primary Outcome Measures
- Stability of anterior chamber and pupil [Intraoperative]
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 [Intraoperative]
To evaluate whether the new method will shorten the operation time
- Cumulative dissipated energy (CDE) [Intraoperative]
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 [Intraoperative]
The incidence of complications, including infusion deprivation syndrome, anterior capsulorhexis extension, iris trauma, descemets detachment, posterior capsular defect, nucleus drop, etc
- Visual acuity (VA) [3 months after opreation]
To evaluate whether the surgery can effectively increase VA.
- Intraocular pressure(IOP) [3 months after opreation]
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 [3 months after opreation]
The incidence of complications, including corneal edema, cystoid macular edema, etc.
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients with visually significant cataract following PPV
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After PPV vitreous substitutes were air / gas (Perfluoropropane:C3F8) or BSS,
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After PPV if vitreous substitute was silicone oil, that should be removed at least 3 months.
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The duration between PPV / silicone oil remove and phacoemulsification should more than 3 months
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Willing and able to comply with clinic visits and study-related procedures
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Provide signed informed consent
Exclusion Criteria:
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Eyes with a history of acute angle-closure glaucoma, trauma,
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Eyes with a clinically dislocated or subluxated lens.
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Active ocular or periocular infection in the study eye
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Uncontrolled Blood Pressure
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Pregnant or breast-feeding women
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Participation in another simultaneous medical investigator or trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University | Xi'an | Shaanxi | China | 710004 |
Sponsors and Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University
Investigators
- Principal Investigator: Ling Bai, MD,PhD, Second affiliated hospital of Xian Jiaotong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRIS hook