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Evaluation of safety and efficacy of extraocular LED-illumination during vitreoretinal surgery

Evaluation of safety and efficacy of extraocular LED-illumination during vitreoretinal surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025483
Enrollment
43
Registered
2021-07-13
Start date
2022-02-24
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 Detachement Proliferative diabetic retinopathy macular pucker vitreous bleeding

Interventions

Group 1: Visit 0 (Screening): - patient information and consent - Visual acuity and contrast sensitivity, intraocular pressure - slit lamp examination including funduscopy in mydriasis - macula OCT,

Sponsors

Universitätsaugenklinik Frankfurt am Main
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - retinal disorders with indication of vitreoretinal surgery - age > 18 years - visual acuity minimum light perception - pseudophakic eyes or cataract until stadium N04NC4C3P3 (LOCS-3)

Exclusion criteria

Exclusion criteria: - pregnancy and breastfeeding - perforating trauma - glaucoma and hypotonic syndrom - clinically relevant lens subluxation - visual impairment due to age-related macula degeneration or vitelliformous maculopathies - acute infections

Design outcomes

Primary

MeasureTime frame
Visualisation of peripheral retina of more than 50%

Secondary

MeasureTime frame
• visualisation of potential retinal breaks with extraocular LED-illumination, time of surgery in total, need and intensity of additional intraocular illumination • exclusion of phototoxic damage to retinal tissue, especially the retinal pigment epithelium • central retinal constistution pre- and postoperatively and constitution of vitreous body preoperatively • developement of visual acuity • contrast sensitivity and qualitiy of vision • influence of retinal pigmentation on transscleral illumination - number of early re-detachement and signs of proliferative vitreoretinopathy • influence of bulbus length on transillumination • exclusion of thermal damage to the sclera and conjunctiva (necrosis) • postoperative hypotony

Countries

Germany

Contacts

Public ContactFrank Koch

Universitätsaugenklinik Frankfurt am Main

fkoch1@icloud.com+49 69(0) 6301 4183

Outcome results

None listed

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