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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if maintaining a special head position for one day after surgery is as effective as doing so for seven days. It focuses on individuals who have undergone surgery to repair a retinal detachment (when the retina separates from its normal position) with a specific type of break. The surgery uses a gas called C3F8 (Perfluoropropane) to aid in retinal healing. Individuals diagnosed with a certain kind of retinal detachment who adhere to post-surgery instructions might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially enhance post-surgery care for retinal detachment.

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 prior data suggests that this head positioning protocol is safe?

Research has shown that using C3F8 gas in eye surgeries, such as for fixing a detached retina, is generally safe and effective. Studies have examined its safety and effectiveness. One real-world study found that the gas was effective and safe for patients during surgery. Another study showed a high success rate in reattaching the retina using C3F8 gas, suggesting the procedure is safe for most people.

Serious side effects are rare, and most patients do not experience major problems. However, like any medical treatment, some risks exist. These might include temporary discomfort or changes in eye pressure. Overall, C3F8 gas has been successfully used in many similar surgeries before. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new post-surgery protocol that could significantly impact recovery for retinal detachment patients. Traditionally, treatments require patients to maintain a specific head position for several days to ensure the gas bubble used in surgery holds the retina in place. This trial is testing if just a one-day head positioning post-surgery can be effective, potentially making recovery more comfortable and convenient for patients. If successful, it could lead to a more patient-friendly approach without compromising surgical outcomes.

What evidence suggests that one day post-operative head positioning is effective for retinal detachment?

Studies have shown that using C3F8 gas in eye surgery to repair a detached retina is highly effective. One study found that over 97% of patients achieved successful retina reattachment with C3F8 gas. This indicates that nearly all patients experienced successful reattachment with this treatment. Another study demonstrated that C3F8 gas outperforms air, particularly for detachments in the lower part of the retina. Overall, research supports the effectiveness of C3F8 gas, making it a reliable choice for repairing a detached retina. Participants in this trial will follow a specific post-operative head positioning regimen after retina reattachment surgery using C3F8 gas. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

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 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]

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 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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10627491/

A Short-Time Real-World Study of Two Perfluoropropane ...

The single-surgery retinal reattachment rates of the pure C3F8 group and mixed C3F8 group were 97.4% and 96.8%, respectively, with no significant difference (p ...

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accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf22/P220030B.pdf

Summary of Safety and Effectiveness Data (SSED)

The applicant performed a systematic clinical literature review to establish a reasonable assurance of safety and effectiveness of the UNIPURE C3F8 Ophthalmic ...

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journalretinavitreous.biomedcentral.com

journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-024-00530-y

versus long-acting gas tamponades in vitrectomy for ...

Our study demonstrates a very similar primary surgical success rate of about 91% with both long-acting gas tamponades (C3F8 or C2F6) and short- ...

4.

aao.org

aao.org/education/editors-choice/gas-tamponade-recommended-retinal-detachment-invol

Gas tamponade recommended for retinal detachment ...

This retrospective review found that gas tamponade is superior to air tamponade in rhegmatogenous retinal detachment (RRD) cases with involvement of the lower ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03714503

Head Positioning After Retina Detachment Repair

Study Objectives: To determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients ...

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researchgate.net

researchgate.net/publication/389950616_Prospective_multicenter_randomized_single-blind_parallel-controlled_clinical_trial_to_evaluate_the_safety_and_efficacy_of_perfluoropropane_for_ophthalmic_surgery

(PDF) Prospective, multicenter, randomized, single-blind, ...

This study aims to evaluate the safety and efficacy of experimental perfluoropropane (C3F8) for intraocular tamponade during vitreoretinal ...

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frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1549152/pdf

Modification of the pneumatic retinopexy for the treatment ...

Following modified PR, retinal attachment was achieved in 9 of the 10 eyes (90%), with all patients receiving only a single 14% C3F8 gas ...