Safety and performance of silicone oil in retinal detachment surgery.

Safety and performance of silicone oil in retinal detachment surgery. - Endotamponades: silicone oil

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38831

Enrollment

300

Registered

2013-12-09

Start date

2014-03-21

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

retinal detachment

Interventions

Intervention is identical to conventional intervention (sterilization is different).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: rhegmatogenous retinal detachment and giant tear, rhegmatogenous retinal detachment and PVR, diabetic tractional detachment with proliferative diabetic retinopathy.

Exclusion criteria

Exclusion criteria: NA.

Design outcomes

Primary

Measure	Time frame
Intraocular pressure, macula attached.	—

Secondary

Measure	Time frame
Preoperatively: Demographic characteristics: gender, age, ethnicity. Preoperatively, at postop day 1 and 14 (± 3), and at week 26 (± 2): Proportion of patients with IOP within 5-25 mm Hg. Proportion of patients with retina attached. Proportion of patients with macula attached. Preoperatively, at week 6 (± 1), 26 (± 2) and 52 (± 4): Visual acuity. Peroperatively: Diagnostic details, surgical procedure. Intaoperative adverse events. At any (other) postoperative visit: Proportion of patients with IOP within 5-25 mm Hg. Proportion of patients with retina attached. Proportion of patients with macula attached. Keratopathy. Silicone oil emulsification. Silicone oil in anterior chamber. Date of silicone oil removal. Additional surgery. Glaucoma medication. Intraocular inflammation. Optic neuropathy or abnormalities of the retinal nerve fibre layer. Cataract classification (LOCS). Other postoperative adverse events/complications.	—

Measure

Time frame

Preoperatively: Demographic characteristics: gender, age, ethnicity. Preoperatively, at postop day 1 and 14 (± 3), and at week 26 (± 2): Proportion of patients with IOP within 5-25 mm Hg. Proportion of patients with retina attached. Proportion of patients with macula attached. Preoperatively, at week 6 (± 1), 26 (± 2) and 52 (± 4): Visual acuity. Peroperatively: Diagnostic details, surgical procedure. Intaoperative adverse events. At any (other) postoperative visit: Proportion of patients with IOP within 5-25 mm Hg. Proportion of patients with retina attached. Proportion of patients with macula attached. Keratopathy. Silicone oil emulsification. Silicone oil in anterior chamber. Date of silicone oil removal. Additional surgery. Glaucoma medication. Intraocular inflammation. Optic neuropathy or abnormalities of the retinal nerve fibre layer. Cataract classification (LOCS). Other postoperative adverse events/complications.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)