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Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

Primary Purpose

Rhegmatogenous Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healaflow
Sponsored by
Tianjin Medical University Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring Healaflow, Rhegmatogenous retinal detachment, 27-gauge Pars plana vitrectomy, Minimally invasive surgery, Complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - patients with primary RRD

Exclusion Criteria: - proliferative vitreoretinopathy grade C or more, dialysis, retinoschisis, eyes with secondary RRD, significant corneal or lens opacity precluding vitrectomy, giant retinal tears, a follow-up period of less than 3 months, and visual loss from causes other than RRD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Healaflow group

    Arm Description

    The Healaflow group consists of patients with primary RRD, but exclude proliferative vitreoretinopathy grade C or more, dialysis, retinoschisis, eyes with secondary RRD, significant corneal or lens opacity precluding vitrectomy, giant retinal tears, a follow-up period of less than 3 months, and visual loss from causes other than RRD.

    Outcomes

    Primary Outcome Measures

    postoperative anatomic outcome
    fundus retina examination through ophthalmoscope, fundus image, B ultrosound

    Secondary Outcome Measures

    BCVA
    BCVA using a Landolt C acuity chart method
    postoperative complications
    postoperative complications

    Full Information

    First Posted
    May 17, 2018
    Last Updated
    April 29, 2019
    Sponsor
    Tianjin Medical University Eye Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03542162
    Brief Title
    Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment
    Official Title
    Patching Retinal Breaks With Healaflow in 27G Vitrectomy for the Treatment of Rhegmatogenous Retinal Detachment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    July 1, 2018 (Actual)
    Study Completion Date
    December 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tianjin Medical University Eye Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To report the surgical results of primary rhegmatogenous retinal detachment (RRD) repaired by 27G pars plana vitrectomy (PPV) combined with Healaflow patch and air tamponade, and do not need prone position postoperation.
    Detailed Description
    To improve the success rates of pars plana vitrectomy(PPV) which is the most common surgical procedure for the repair of primary rhegmatogenous retinal detachment (RRD) and to avoid silicon oil tamponade and face-down position, all eyes enrolled into this clinical trail undergo 27G PPV combined with Healaflow patch and air tamponade which do not need face-down position in the postoperative period. Healaflow® (Anteis S.A., Plan Les Ouates, Switzerland) consists of over 97% water, sodium hyaluronic acid (22.5 mg/ml) of nonanimal origin cross-linked with BDDE (1.4-Butanediol diglycidyl ether), and phosphate- and NaCl-salts to maintain a physiological pH (7.0) and osmolarity (305 mOsm/kg). At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure(IOP) will be measured and fundoscopy, OCT, B-ultrasound will be performed. The patients are going to be followed up for at least 3 months, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhegmatogenous Retinal Detachment
    Keywords
    Healaflow, Rhegmatogenous retinal detachment, 27-gauge Pars plana vitrectomy, Minimally invasive surgery, Complications

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    All patients who meet the criteria and agree to paticipate in the clinical study, will be enrolled to this study after signing informed consent.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healaflow group
    Arm Type
    Experimental
    Arm Description
    The Healaflow group consists of patients with primary RRD, but exclude proliferative vitreoretinopathy grade C or more, dialysis, retinoschisis, eyes with secondary RRD, significant corneal or lens opacity precluding vitrectomy, giant retinal tears, a follow-up period of less than 3 months, and visual loss from causes other than RRD.
    Intervention Type
    Biological
    Intervention Name(s)
    Healaflow
    Intervention Description
    For the RRD patients, after 27G PPV, air-liquid exchange and endolaser photocoagulation around the tear(s), Healaflow is going to be fully covered on the surface of all retinal tears using 27G needle, the amount of Healaflow injection was determined according to the size of tears.
    Primary Outcome Measure Information:
    Title
    postoperative anatomic outcome
    Description
    fundus retina examination through ophthalmoscope, fundus image, B ultrosound
    Time Frame
    baseline to 3 months post-surgery
    Secondary Outcome Measure Information:
    Title
    BCVA
    Description
    BCVA using a Landolt C acuity chart method
    Time Frame
    baseline to 3 months post-surgery
    Title
    postoperative complications
    Description
    postoperative complications
    Time Frame
    baseline to 3 months post-surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - patients with primary RRD Exclusion Criteria: - proliferative vitreoretinopathy grade C or more, dialysis, retinoschisis, eyes with secondary RRD, significant corneal or lens opacity precluding vitrectomy, giant retinal tears, a follow-up period of less than 3 months, and visual loss from causes other than RRD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaorong Li, MD, PhD
    Organizational Affiliation
    Tianjin Medical University Eye Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

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