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Sclerotomy Sealing by Ultrasound

Sclerotomy Sealing by Ultrasound

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038484
Enrollment
60
Registered
2025-12-15
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients undergoing 23G vitrectomy for epiretinal membrane, macular hole, vitreomacular traction, vitreous hemorrhage, vitreous opacities, diabetic retinopathy, or retinal detachment.

Interventions

Group 1: Controll group: Patients undergoing 23-gauge vitrectomy. After trocar removal and a waiting period of 3 minutes, sclerotomies are checked for leakage. Leaking sclerotomies are sutured with Vi

Sponsors

SLK-Kliniken Heilbronn
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Planned vitrectomy with or without phacoemulsification in adults (indications: epiretinal membrane, macular hole, vitreous hemorrhage, vitreous opacities, retinal detachment) Informed consent for study participation

Exclusion criteria

Exclusion criteria: Previous vitrectomy Complicated procedures with vitreoretinal surgery time (time between trocar insertion and removal) exceeding 60 minutes Myopia of 10 diopters or more, or axial length of 26 mm or more Combined vitreoretinal and scleral buckling surgery Use of silicone oil tamponade Vitrectomy for endophthalmitis 4-port vitrectomy Additional surgical procedures on the conjunctiva requiring sutures

Design outcomes

Primary

MeasureTime frame
Number of leaking/sutured sclerotomies per patient. Immediately postoperative, as well as during the postoperative period, should additional suturing be required. Scoring system according to the number of leaking sclerotomies per eye (0-3).

Secondary

MeasureTime frame
Intraocular pressure at timepoints T0 (preoperative), T1 (immediately postoperative), T2 (24h postoperative), T3 (discharge, 2-4 days), T4 (10-14 days postoperative), T5 (4 weeks postoperative) Hypotony rate (intraocular pressure <6 mmHg at any postoperative timepoint), clinical signs of hypotony Discomfort: pain and foreign body sensation on visual analog scale (0-10) at timepoints T2, T3, T4, T5 Endothelial cell count at timepoints T0, T5 Sclerotomy closure or gaping, measured by anterior segment OCT

Countries

Germany

Contacts

Public ContactLutz Hesse

SLK-Kliniken Heilbronn

lutz.hesse@slk-kliniken.de+4971314931100

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026