Head Positioning Post-Surgery for Retinal Detachment

Overseen By Abby Strickland

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Pediatric, Pregnant, Previous repair, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment using C3F8 gas tamponade for retinal detachment?

Research shows that using C3F8 gas in retinal detachment surgery is effective, with a high reattachment rate of over 95% in some studies. It is also noted for its ability to simplify the treatment of complex retinal conditions and maintain the reattachment over time. ^{1 2 3 4 5}

Is the use of C3F8 gas for retinal detachment surgery safe?

C3F8 gas is generally considered safe for use in retinal detachment surgeries, as it is nontoxic and slowly absorbable. However, it may cause increased eye pressure shortly after surgery, which should be monitored and managed by healthcare providers. ^{1 2 6 7 8}

How does the C3F8 gas treatment for retinal detachment differ from other treatments?

The C3F8 gas treatment for retinal detachment is unique because it uses a long-lasting gas bubble to help reattach the retina, providing internal support for an extended period compared to other gases or air. This can increase the success rate of retinal reattachment, although it may also lead to higher intraocular pressure post-surgery. ^{1 3 8 9 10}

What is the purpose of this trial?

This study aims to determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV) using perfluoropropane (C3F8) gas as a tamponade. The investigator will conduct a single arm phase II study using a Simon's two-stage design

Eligibility Criteria

This trial is for adults over 18 with a specific eye condition called primary rhegmatogenous retinal detachment that includes inferior breaks. Participants must understand the study and agree to sign consent. Women able to have children must test negative in a pregnancy test before surgery.

Inclusion Criteria

I have been diagnosed with a specific type of retinal detachment.

I agree to take a pregnancy test before surgery and it must be negative.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

I have fluid under my retina causing it to detach.

My retina has detached and I have not had cataract surgery.

I have a retinal detachment that hasn't caused symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pars plana vitrectomy (PPV) with C3F8 gas tamponade and one day post-operative prone head positioning

1 day

Follow-up

Participants are monitored for retina anatomical success post-operatively

3 months

Extended Follow-up

Participants are further monitored for retina anatomical success at 1 year post-operatively

1 year

Treatment Details

Interventions

• Retina re-attachment repair using C3F8 gas tamponade

Trial Overview The study tests if staying face-down for one day after retina re-attachment surgery using C3F8 gas is as effective as seven days of the same posture. It's a phase II trial, meaning it's early in testing but past initial safety checks.

Participant Groups

Group I: One day post-operative head positioning Experimental Treatment 1 Intervention

patients will be assigned to remain a one-day post operative head positioning following retina re-attachment surgery

Retina re-attachment repair using C3F8 gas tamponade is already approved in United States for the following indications:

Approved in United States as UNIPURE C3F8 Ophthalmic Gas for:

• Uncomplicated retinal detachments

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

In a study of 578 patients with rhegmatogenous retinal detachment, both air and C3F8 gas tamponade showed similar primary reattachment rates (95.03% for air and 95.34% for C3F8), indicating comparable efficacy in surgical outcomes.

Air tamponade resulted in a shorter time for the intraocular bubble to disappear and a lower incidence of postoperative intraocular pressure spikes compared to C3F8, suggesting it may be a safer and more cost-effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Air versus Perfluoropropane Gas in Pars Plana Vitrectomy for Primary Rhegmatogenous Retinal Detachment: A 3-Year Retrospective Study. Qian, T., Suo, Y., Ma, Y., et al.[2023]

Perfluoropropane (C3F8) is a safe and effective gas used in retinal detachment surgery, as it is non-toxic and slowly absorbed, making it ideal for intravitreal tamponade.

In a study of 120 cases, C3F8 injections improved surgical outcomes by simplifying the treatment of macular holes and aiding in the reattachment of retinal flaps during vitrectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Perfluoropropane for the treatment of retinal detachment]. Zhang, X.[2014]

In a study involving 18 patients with retinal detachment and proliferative vitreoretinopathy, the use of perfluoropropane (C3F8) gas as an adjunct to vitreous surgery resulted in 10 patients having reattached retinas after six months.

The average duration that the gas remained effective in successful cases was 92 days, suggesting that longer-lasting gases may enhance the rate of retinal reattachment, although the difference in gas longevity between successful and failed cases was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perfluoropropane gas in the management of proliferative vitreoretinopathy. Chang, S., Coleman, DJ., Lincoff, H., et al.[2019]

In a study of 1023 cases of primary retinal detachment, there was no significant difference in treatment success between air and fluorinated gas tamponades (20% SF6 or 14% C3F8), indicating both methods are equally effective.

This finding holds true even for cases with inferior retinal defects, suggesting that the choice of tamponade type does not impact the re-detachment rates or overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Air versus fluorinated gas tamponades in pars plana vitrectomy treatment for primary rhegmatogenous retinal detachment. Govers, BM., Lamers, MPM., Klevering, BJ., et al.[2022]

In a study of 28 patients with rhegmatogenous retinal detachment treated with pneumatic retinopexy using C3F8 gas, a successful reattachment rate of 78.6% was achieved after one treatment.

Postoperative complications included proliferative vitreoretinopathy (PVR) in 10.7% of eyes and new retinal breaks in 7.1%, indicating that while the treatment is effective, there are notable risks involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of pneumatic retinopexy. Kovacević, D., Bedenicki, I.[2014]

In a study of 34 patients with retinal detachment and proliferative vitreoretinopathies, the use of C3F8 gas during posterior vitrectomy resulted in complete retinal attachment in all cases, demonstrating its efficacy as an internal tamponade.

The combination of vitrectomy with C3F8 gas and additional procedures like episcleral buckling and laser coagulation is an effective treatment for complex retinal detachments, although the success may vary based on the severity of the underlying vitreoretinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of surgical treatment of retinal detachments complicated with proliferative vitreoretinopathies with the use of perfluropropane (C3F8) gas. Vardanyan, AH., Hovakimyan, AV., Hambartsumyan, AV.[2014]

In complex retinal detachment cases, perfluoropropane (C3F8) is commonly used after vitrectomy to help seal retinal breaks, but studies show significant variability in how quickly C3F8 disappears from the eye.

The decay rate and half-life of C3F8 can differ greatly among patients, even when they have similar conditions and received the same concentration, indicating that individual responses to the treatment can vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation of perfluoropropane disappearance after vitrectomy. Meyers, SM., Ambler, JS., Tan, M., et al.[2019]

In a study of 132 patients with retinal detachment, both pure and mixed C3F8 tamponade methods showed high retinal reattachment rates of 97.4% and 96.8% after a single surgery, indicating their efficacy in treating this condition.

The pure C3F8 method was found to be more convenient and required less gas configuration and dosage compared to the mixed C3F8 method, while both methods had similar safety profiles regarding intraocular pressure changes and postoperative inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Short-Time Real-World Study of Two Perfluoro Propane Tamponade Methods in Pars Plana Vitrectomy for Retinal Detachment. Tan, S., Wu, S., Miao, J., et al.[2023]

In a study of 62 eyes from 61 patients with retinal detachment due to giant retinal tears, perfluorocarbon liquid was used as a short-term tamponade, resulting in a high success rate of retinal reattachment (93.5%) after a mean follow-up of 24.5 months.

The use of perfluorocarbon liquid was found to be safe, with no retained liquid in any eyes and only a small percentage (22.6%) experiencing re-detachment, while visual acuity improved in over half of the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitrectomy with short term postoperative tamponade using perfluorocarbon liquid for giant retinal tears. Sirimaharaj, M., Balachandran, C., Chan, WC., et al.[2018]

In a study of 40 eyes from 39 patients with primary rhegmatogenous retinal detachment, a minimally restricted face-down positioning after surgery resulted in a high anatomical success rate of 90% immediately after surgery and 100% at the final follow-up, indicating effective treatment.

Patients experienced significant improvement in best-corrected visual acuity, with scores improving from 0.75 logMAR preoperatively to 0.12 logMAR at the final visit, demonstrating both safety and efficacy of the postoperative positioning strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary rhegmatogenous retinal detachment: evaluation of a minimally restricted face-down positioning after pars plana vitrectomy and gas tamponade. Kusaba, K., Tsuboi, K., Handa, T., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Air versus Perfluoropropane Gas in Pars Plana Vitrectomy for Primary Rhegmatogenous Retinal Detachment: A 3-Year Retrospective Study. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Perfluoropropane for the treatment of retinal detachment]. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Perfluoropropane gas in the management of proliferative vitreoretinopathy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Air versus fluorinated gas tamponades in pars plana vitrectomy treatment for primary rhegmatogenous retinal detachment. [2022]

5. Croatia pubmed.ncbi.nlm.nih.gov

Complications of pneumatic retinopexy. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Results of surgical treatment of retinal detachments complicated with proliferative vitreoretinopathies with the use of perfluropropane (C3F8) gas. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Variation of perfluoropropane disappearance after vitrectomy. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Short-Time Real-World Study of Two Perfluoro Propane Tamponade Methods in Pars Plana Vitrectomy for Retinal Detachment. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Vitrectomy with short term postoperative tamponade using perfluorocarbon liquid for giant retinal tears. [2018]

10. China pubmed.ncbi.nlm.nih.gov

Primary rhegmatogenous retinal detachment: evaluation of a minimally restricted face-down positioning after pars plana vitrectomy and gas tamponade. [2021]