Temporary gas injection into the eye to help stabilize the retina in adults with retinal detachment before vitrectomy surgery

Preoperative C3F8 injection as a temporary macular tamponade in macula-off rhegmatogenous retinal detachments in candidates to pars plana vitrectomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29200092

Enrollment

Registered

2025-10-10

Start date

2025-10-03

Completion date

Unknown

Last updated

2025-10-20

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

Conditions

Rhegmatogenous Retinal Detachment - Macula Off Eye Diseases

Interventions

Intervention: pneumatic retinopexy of C3F8 before vitrectomy surgery Control: vitrectomy surgery only The date of the vitrectomy is independent of the treatment arm. 1:1 randomization with randomiza

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 30-90 years old 2. Primary macula-off rhegmatogenous retinal detachment with a maximum 2 weeks (14 days) of central vision loss at presentation 3. Rhegmatogenous retinal detachment not suitable for pneumatic retinopexy alone without vitrectomy because of extension, multiple tears, inferior localization or multiple lattice

Exclusion criteria

Exclusion criteria: 1. Proliferative vitreoretinopathy grade B or C 2. Tractional or serous detachments 3. Presence of other ophthalmological diseases that have an effect on visual acuity (potential confounders): terminal glaucoma, neuropathy, history of posterior uveitis, previous macular pathology 4. Macula-split retinal detachments 5. Patients not able to maintain postoperative positioning 6. Patients who present with a central vision loss of more than 2 weeks (14 days)

Design outcomes

Primary

Measure	Time frame
Visual acuity measured using ETDRS letters at 3 months	—

Secondary

Measure	Time frame
1. Macular reattachment rate measured by the proportion of macular reattachment in both groups at 3 months 2. Presence of new tears measured using proportion of patients with new tears at 3 months 3. New or progression of proliferative vitreoretinopathy measured using rate of PVR developing or progression (using standard PVR grading) at 3 months. 4. Accordance of tamponade selection using accordance ratio of preoperative assessments and actual tamponade use at time of surgery. 6. Retinal displacement rate measured in proportion at 3 month 7. Number of total surgeries needed at 3 months	—

Measure

Time frame

1. Macular reattachment rate measured by the proportion of macular reattachment in both groups at 3 months 2. Presence of new tears measured using proportion of patients with new tears at 3 months 3. New or progression of proliferative vitreoretinopathy measured using rate of PVR developing or progression (using standard PVR grading) at 3 months. 4. Accordance of tamponade selection using accordance ratio of preoperative assessments and actual tamponade use at time of surgery. 6. Retinal displacement rate measured in proportion at 3 month 7. Number of total surgeries needed at 3 months

—

Countries

Canada

Contacts

Public ContactShigufa K. Ali

shigufa.kahn.ali.cemtl@ssss.gouv.qc.ca+1 514-252-3400 poste 4948

Outcome results

None listed

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