Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610786
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Use of FCSB in Medium-complex RRD - a Safety and Efficacy Evaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FCSB
Brief Summary:
The objective of the study is to evaluate
1 Safety and efficacy of a novel foldable capsular scleral buckle FCSB in scleral buckling for primary rhegmatogenous retinal detachment RRD of medium complexity
2 Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity
1 Safety and efficacy of a novel foldable capsular scleral buckle FCSB in scleral buckling for primary rhegmatogenous retinal detachment RRD of medium complexity
2 Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity
Detailed Description:
Pars plana vitrectomy PPV and scleral buckling SB are major choices in treating rhegmatogenous retinal detachment RRD of medium complexity PPV is more prevailed since it improved internal search for breaks and elimination of vitreous traction SB has unmatched advantages over PPV such as earlier rehabilitation free from prolonged positioning less complicated cataract or glaucoma The novel foldable capsular scleral buckle FCSB can create a big bulge by pressing on the sclera and seal the break in bullous RRD without scleral drainage In the study differences of anatomic and functional results between PPV and FCSB in treating primary RRD of medium complexity are evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None