Rhegmatogenous Retinal Detachment
Conditions
Keywords
Healaflow, Rhegmatogenous retinal detachment, 27-gauge Pars plana vitrectomy, Minimally invasive surgery, Complications
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.
Interventions
BIOLOGICALHealaflow
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.
Sponsors
Tianjin Medical University Eye Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative anatomic outcome | baseline to 3 months post-surgery | fundus retina examination through ophthalmoscope, fundus image, B ultrosound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA | baseline to 3 months post-surgery | BCVA using a Landolt C acuity chart method |
| postoperative complications | baseline to 3 months post-surgery | postoperative complications |
Outcome results
None listed