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Traction-free vitreous body removal: the evaluation of the safety and effectiveness within the framework of 3 pathologies in operative retinal and vitreous body surgery

Traction-free vitreous body removal: the evaluation of the safety and effectiveness within the framework of 3 pathologies in operative retinal and vitreous body surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00026046
Enrollment
44
Registered
2021-08-12
Start date
2020-12-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment, Macular Disease, Diabetic Retinopathy

Interventions

Group 1: patients receive pars plana vitrectomy performed using Vitesse hypersonic vitrectomy device

Sponsors

University Hospital Frankfurt Department of Ophthalmology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients requiring one or more intraocular surgical interventions with 3 clinical pictures (macular diseases, retinal detachments, diabetic retinopathy), ability to give consent, signed patient consent, age equal to or greater than 18 years

Exclusion criteria

Exclusion criteria: Condition after a serious eye injury, pregnant or breastfeeding, age less than 18 years

Design outcomes

Primary

MeasureTime frame
Safety endpoint: Interoperative and postoperative adverse events

Secondary

MeasureTime frame
Performance endpoints: Effectiveness assessed by surgeon (post-operative questionnaire which is completed directly following the surgery within the first 24 hrs post operatively), duration of operation, device settings. Other performance measurements: Development of vision (visual acuity pre- and post-operative), findings from slit lamp and indirect ophthalmoscopy, applanation tonometry, color fundus photography, optical coherence tomography, signs of proliferative vitreoretinopathy, influence of the eye axis length, retinal condition / pretreatment

Countries

Germany

Contacts

Public ContactFrank Koch

University Hospital Frankfurt, Department of Ophthalmology

fkoch1@me.com01727587518

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026