EyeEntFudan
Shanghai, Shanghai Municipality, 200031, China
Location contact
Zhongcui Sun, PhD
CONTACT
Zhongcui Sun, PhD
CONTACT
ruiping Gu, phD
CONTACT
NCT Number: NCT06610786
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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200031, China
Zhongcui Sun, PhD
CONTACT
Zhongcui Sun, PhD
CONTACT
ruiping Gu, phD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
One or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction)
Exclusion criteria
Using foldable capsular vitreous body as a novel scleral buckle material to treat the primary rhegmatogenous retinal detachment (RRD) of medium complexity
Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity.
Time frame: From enrollment to the end of treatment at 6 months
The success rate of retinal reattachment
Time frame: From enrollment to the end of treatment at 6 months
metamorphopsia is measured by M chart
Time frame: From enrollment to the end of treatment at 6 months
Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision
Time frame: From enrollment to the end of treatment at 6 months
The number of surgeries the patient undergoes to achieve final retinal reattachment
Time frame: From enrollment to the end of treatment at 6 months
Surgical Complications, included EOM dysfunction,Choroidal detachment,Clinical CME,Macular pucker,Postoperative IOP >21 mmHg with medications
Eye & ENT Hospital of Fudan University
Other
The Use of FCSB in Medium-complex RRD - a Safety and Efficacy Evaluation
Acronym: FCSB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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