Spots Global Cancer Trial Database for PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery

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Trial Identification

Brief Title: PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery

Official Title: Post-Marketing Clinical Follow-up (PMCF) Study in Ophthalmic Surgery to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter Randomized, Active-controlled, Double-blinded, Prospective, Observational Study.

Study ID: NCT02761083

Conditions

Dacryocystorhinostomy

Ectropion

Entropion

Ptosis

Eyelid Tumor Resection

Blepharoplasty

Interventions

Novosyn® Quick

Vicryl® Rapid

Study Description

Brief Summary: The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with standard suture material used in Ophthalmic surgery. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be compared in 2 treatment groups. Active control group will receive Vicryl® Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to design this study as a randomized trial, because limited clinical evidence is available in the literature for the active control group (Vicryl® Rapide) which can be used for comparison. Eye operation will be randomly allocated on the left and right side (1:1) to both treatment groups. Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, blepharoplasty)

Detailed Description: