The clinical trial of cross-lined sodium hyaluronate gel for patching retinal breaks: a multicentre, randomized, open-label, parallel control clinical trial.

The efficacy and safty of patching retinal breaks with linear cross-lined sodium hyaluronate gel for the treatment of rhegmatogenous retinal detachment: a multicentre, randomized, open-label, parallel control clinical trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037030

Enrollment

Unknown

Registered

2020-08-26

Start date

2020-08-01

Completion date

Unknown

Last updated

2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rhegmatogenous retinal detachment

Interventions

Experimental group:linear cross-lined sodium hyaluronate gel intraocular implantation

control group:C3F8 gas intraocular tamponade

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. The patient is diagnosed as RRD; 3. The classification of PVR is grade A or grade B; 4. The patient need a treatement of vitreoretinal surgery by the judgement of investigator; 5. The patient can understand the objective of this clinical trial. He volunteered to participate, would signed the ICF, and promised to finish the visit after operation on time.

Exclusion criteria

Exclusion criteria: 1. Complicated with choroid detachment; 2. With macular hole; 3. With giant retinal break by investigator (the range of retinal break over 1 quadrant); 4. With any abnomality as corneal ulcer, conjunctivitis, scleritis, uveitis, and other infective or non-infective eye disease; 5. With any ocular trauma, ocular oncology, glaucoma, and other eye disease needing further treatment; 6. The operation eye has the contraindication of vitrectomy; 7. With serious or unstable systemic disease; 8. The fasting blood-glucose before operation equal or greater than 9 mmol/L; 9. participated in other medicine or medical device clinical trial within 30 days by screening; 10. With the history of intraocular surgery within 3 months by screening; 11. The fellow eye is non-functional or with low vision by the judgement of investigatior; 12. In gestation period or lactation period, or the patient has a plan for pregnancy; 13. Not suitable of inclusion in other situation by the judgement of investigator.

Design outcomes

Primary

Measure	Time frame
retinal reattachment rate;	—

Secondary

Measure	Time frame
the improvement of the best corrected distance visual acuity;Incidence rate of second operation for retinal reattachment;	—

Countries

China

Contacts

Public ContactWenji Wang

Shanghai Qisheng Medical Technology Development Co., Ltd.

wangwenji@3healthcare.com+86 021-62260793

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026