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Vitrectomy plus Encircling Band vs. Vitrectomy alone for the Treatment of Pseudophakic Retinal Detachment (VIPER)

Not Applicable
Completed
Conditions
pseudophakic retinal detachment
H33.0
Retinal detachment with retinal break
Registration Number
DRKS00003158
Lead Sponsor
niversitätsklinikum Aachen, AÖR - Medizinische Fakultät der RWTH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
257
Inclusion Criteria

Age: 18 years or older
- Pseudophakic rhegmatogenous retinal detachment not suitable for buckling surgery
- Agreement of the patient to participate in the trial
- Written informed consent of the patient

Exclusion Criteria

•Manifest uveitis
•Uncontrolled glaucoma
•Active retinal vascular disease
•Malignant intraocular eye tumours
•History of cataract surgery less than 3 months ago
•History of any other intraocular surgery other than cataract surgery
•Giant retinal tears
•PVR grade B or C
•Inability to understand the rationale of this trial or the study aim
•Participation in another clinical trial (less than 3 months ago)
•Aphakia
•Systemic disorders preventing the participation of control examinations during the follow-up
•Systemic disorders not compatible with the local periocular or general anesthesia

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Absence of an indication for any retina reattaching procedure during the follow-up of 26 weeks; such procedures are additional gas injections, additional vitrectomy or additional buckling procedure
Secondary Outcome Measures
NameTimeMethod
- Visual acuity at the end of follow-up as measured by ETDRS charts<br><br>- Refractive status<br><br>- Anatomical situation of the anterior and posterior segment<br><br>- Retina reattachment rate<br><br>- Occurrence of PVR<br><br>- Occurrence of adverse events<br><br>- Number of retina specific procedures to achieve a stable retinal attachment<br><br>These data will obtained after 6 months of follow-up.
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