NCT02761083

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

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.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Dacryocystorhinostomy
• Ectropion
• Entropion
• Ptosis
• Eyelid Tumor Resection
• Blepharoplasty

Interventions

Type	Name	Description
DEVICE	Novosyn® Quick	Eye surgery
DEVICE	Vicryl® Rapid	Eye surgery

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-03-01
• Completion: 2017-09-01
• First posted: 2016-05-04
• Last updated: 2016-06-10

Locations

1 site across 1 country: Spain