IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

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 Overview

• Status: Completed
• Conditions: Cataract; Vitrectomy
• Intervention / Treatment: Device: IRIS HOOK; Device: TRADITION

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative
Time of operation	To evaluate whether the new method will shorten the operation time	Intraoperative
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.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intraoperative
Visual acuity (VA)	To evaluate whether the surgery can effectively increase VA.	3 months after opreation
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.	3 months after opreation
The presence of postoperative complications	The incidence of complications, including corneal edema, cystoid macular edema, etc.	3 months after opreation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
• Investigators: Principal Investigator: Ling Bai, MD,PhD, Second Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IRIS hook

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No