IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

Xi'an Jiaotong University

Status: Completed

Conditions: Vitrectomy; Cataract

Treatments: Device: TRADITION; Device: IRIS HOOK

Study type: Interventional

Funder types: Other

Identifiers

NCT03584139

IRIS hook

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

IRIS HOOK

Experimental group

Description:

iris hook assisted maneuver in phacoemulsification

Treatment:

Device: IRIS HOOK

TRADITION

Active Comparator group

Description:

traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation

Treatment:

Device: TRADITION