Retina Detachment Clinical Trial
Official title:
Pneumatic Retinopexy Preceded by Drainage of Subretinal Fluid for the Treatment of Severe Bullous Retinal Detachment
NCT number | NCT04139746 |
Other study ID # | Vitreo004 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | June 30, 2019 |
Verified date | October 2019 |
Source | Università degli Studi di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the efficacy and safety outcomes of scleral buckling (SB) and drainage-injection-pneumoretinopexy (DIP), a modified pneumatic retinopexy technique, in which, before injecting the gas, the drainage of the subretinal fluid is performed with a simultaneous injection of balanced salt solution (BSS) in the vitreous chamber, for the treatment of severe superior bullous rhegmatogenous retinal detachment (SBRD).
Status | Completed |
Enrollment | 58 |
Est. completion date | June 30, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 60 Years |
Eligibility |
Inclusion Criteria: - provision of written informed consent; - phakic patients aged < 60 years with no or minimal media opacity; - single or multiple retinal breaks (within 1 clock hour) between 8 to 4 o'clock hours; - patients' capability to maintain suggested head positioning for 5 days after the procedure. Exclusion Criteria: - retinal detachment with poor subretinal fluid (absence of severe SBRD); - holes, lattice degeneration or traction within the inferior 4 clock hours; - posterior retinal break, situated behind the equator, not suitable for cryotherapy; - any sign of PVR or severe glaucoma; - myopia above 10 diopters. |
Country | Name | City | State |
---|---|---|---|
Italy | Spedali Civili di Brescia | Brescia | BS |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Brescia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anatomical reattachment of the retina | 12-month | ||
Secondary | Refractive error change | 12-month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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