Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542162
• Other study ID #: 2016-KY18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2019
• Source: Tianjin Medical University Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Eye Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative anatomic outcome	fundus retina examination through ophthalmoscope, fundus image, B ultrosound	baseline to 3 months post-surgery
Secondary	BCVA	BCVA using a Landolt C acuity chart method	baseline to 3 months post-surgery
Secondary	postoperative complications	postoperative complications	baseline to 3 months post-surgery