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Completed

NCT Number: NCT03584139

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710004, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with visually significant cataract following PPV
  • After PPV vitreous substitutes were air / gas (Perfluoropropane:C3F8) or BSS,
  • After PPV if vitreous substitute was silicone oil, that should be removed at least 3 months.
  • The duration between PPV / silicone oil remove and phacoemulsification should more than 3 months
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Exclusion criteria

  • Eyes with a history of acute angle-closure glaucoma, trauma,
  • Eyes with a clinically dislocated or subluxated lens.
  • Active ocular or periocular infection in the study eye
  • Uncontrolled Blood Pressure
  • Pregnant or breast-feeding women
  • Participation in another simultaneous medical investigator or trial

Treatment and study plan

IRIS HOOK

Device

iris hook assisted maneuver in phacoemulsification

TRADITION

Device

traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation

Primary outcomes

  1. Stability of anterior chamber and pupil

    Time frame: 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.

  2. Time of operation

    Time frame: Intraoperative

    To evaluate whether the new method will shorten the operation time

  3. Cumulative dissipated energy (CDE)

    Time frame: 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 outcomes

  1. The presence of intraoperative complications

    Time frame: Intraoperative

    The incidence of complications, including infusion deprivation syndrome, anterior capsulorhexis extension, iris trauma, descemets detachment, posterior capsular defect, nucleus drop, etc

  2. Visual acuity (VA)

    Time frame: 3 months after opreation

    To evaluate whether the surgery can effectively increase VA.

  3. Intraocular pressure(IOP)

    Time frame: 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.

  4. The presence of postoperative complications

    Time frame: 3 months after opreation

    The incidence of complications, including corneal edema, cystoid macular edema, etc.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2018
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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