IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

Cataract Clinical Trial

Official title:

IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584139
• Other study ID #: IRIS hook
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Vitrectomy

Intervention

Device:
• IRIS HOOK
iris hook assisted maneuver in phacoemulsification
• TRADITION
traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation

Locations

Country	Name	City	State
China	Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time of operation	To evaluate whether the new method will shorten the operation time	Intraoperative
Primary	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	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
Secondary	Visual acuity (VA)	To evaluate whether the surgery can effectively increase VA.	3 months after opreation
Secondary	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
Secondary	The presence of postoperative complications	The incidence of complications, including corneal edema, cystoid macular edema, etc.	3 months after opreation