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Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

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ClinicalTrials.gov Identifier: NCT03542162
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Zhenchuan Zheng, Tianjin Medical University Eye Hospital

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.

Condition or disease Intervention/treatment Phase
Rhegmatogenous Retinal Detachment Biological: Healaflow Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Patching Retinal Breaks With Healaflow in 27G Vitrectomy for the Treatment of Rhegmatogenous Retinal Detachment
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healaflow group
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.
Biological: Healaflow
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 Measures :
  1. postoperative anatomic outcome [ Time Frame: baseline to 3 months post-surgery ]
    fundus retina examination through ophthalmoscope, fundus image, B ultrosound


Secondary Outcome Measures :
  1. BCVA [ Time Frame: baseline to 3 months post-surgery ]
    BCVA using a Landolt C acuity chart method

  2. postoperative complications [ Time Frame: baseline to 3 months post-surgery ]
    postoperative complications



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


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): NCT03542162


Sponsors and Collaborators
Tianjin Medical University Eye Hospital
Investigators
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Principal Investigator: Xiaorong Li, MD, PhD Tianjin Medical University Eye Hospital

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Responsible Party: Zhenchuan Zheng, Principal investigator, Tianjin Medical University Eye Hospital
ClinicalTrials.gov Identifier: NCT03542162     History of Changes
Other Study ID Numbers: 2016-KY18
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
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
Keywords provided by Zhenchuan Zheng, Tianjin Medical University Eye Hospital:
Healaflow
Rhegmatogenous retinal detachment
27-gauge Pars plana vitrectomy
Minimally invasive surgery
Complications
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases