Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

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.

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Key information

Conditions

Rhegmatogenous Retinal Detachment

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Healaflow

Biological

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 outcomes

postoperative anatomic outcome

Time frame: baseline to 3 months post-surgery

fundus retina examination through ophthalmoscope, fundus image, B ultrosound

Secondary outcomes

BCVA

Time frame: baseline to 3 months post-surgery

BCVA using a Landolt C acuity chart method
postoperative complications

Time frame: baseline to 3 months post-surgery

postoperative complications

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Eye Hospital

Other

Registry information

Official study title

Patching Retinal Breaks With Healaflow in 27G Vitrectomy for the Treatment of Rhegmatogenous Retinal Detachment

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 31, 2018
Registry last updated: Apr 30, 2019

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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Completed