IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

Not Applicable

Completed

• Conditions: Vitrectomy; Cataract
• Interventions: Device: IRIS HOOK; Device: TRADITION

• Registration Number: NCT03584139
• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

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.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-12
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IRIS HOOK	IRIS HOOK	iris hook assisted maneuver in phacoemulsification
TRADITION	TRADITION	traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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.
The presence of postoperative complications	3 months after opreation	The incidence of complications, including corneal edema, cystoid macular edema, etc.
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.

Trial Locations

Locations (1)

Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China