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IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

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ClinicalTrials.gov Identifier: NCT03584139
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bai Ling, 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.


Condition or disease Intervention/treatment Phase
Cataract Vitrectomy Device: IRIS HOOK Device: TRADITION Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584139


Contacts
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Contact: Ling Bai, MD,PhD +86-29-87679449 larkling@163.com
Contact: Shu Zhang, MD,PhD +86-29-87679208 drzhangshu@163.com

Locations
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China, Shaanxi
Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710004
Contact: Ling Bai, MD,PhD         
Sponsors and Collaborators
Second Affiliated Hospital of Xi'an Jiaotong University
Investigators
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Principal Investigator: Ling Bai, MD,PhD Second affiliated hospital of Xian Jiaotong University

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Responsible Party: Bai Ling, Associated Professor, Second Affiliated Hospital of Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03584139     History of Changes
Other Study ID Numbers: IRIS hook
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases