Ptosis Clinical Trial
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.
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)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02226016 -
Levator Muscle Strength Evaluation
|
N/A | |
| Completed |
NCT01430247 -
Vision Screening for the Detection of Amblyopia
|
N/A | |
| Recruiting |
NCT02959697 -
Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
|
N/A | |
| Terminated |
NCT02878694 -
Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04714424 -
Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues
|
||
| Not yet recruiting |
NCT04007276 -
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
|
Phase 4 | |
| Completed |
NCT02376556 -
The Effect of Eyelid Surgery on Dry Eye - a Prospective Study
|
||
| Completed |
NCT02201979 -
Laser Fluorescent Imaging of Nipple and Areola During Breast Lift
|
N/A | |
| Recruiting |
NCT03375879 -
Bandage Contact Lens in Post Operative Ptosis Patients
|
N/A | |
| Recruiting |
NCT05746078 -
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis.
|
||
| Withdrawn |
NCT03266081 -
Bupivacaine Epiphora Trial
|
Phase 2 |