Surgical Techniques + Gas Tamponade for Retinal Detachment

(REDOS Trial)

Overseen By Julie Mauger, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Disqualifiers: Proliferative vitreoretinopathy, Chronic RRD, others

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

Compensation: Varies

Number of Visits: 1

560 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve surgical techniques for repairing retinal detachment, a condition where the retina peels away from its underlying support tissue, potentially leading to vision loss. It compares two surgical methods: one using only vitrectomy (removal of the gel inside the eye) and another combining vitrectomy with a scleral buckle (a silicone band). The trial also tests two types of gas used to aid retinal healing: Perfluoropropane gas and Sulfur hexafluoride gas tamponade. Individuals with a recent diagnosis of rhegmatogenous retinal detachment, who have had it for less than three months and do not have certain other eye conditions, may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to advancements in surgical techniques that could benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these surgical techniques and gas tamponades are safe for retinal detachment repair?

A previous study on pars plana vitrectomy, which uses sulfur hexafluoride (SF6) gas, showed a high success rate. The procedure closed the retina in 93.2% of cases on the first attempt and achieved complete closure in all cases eventually. Complications were rare, with only one reported case of a retinal tear caused by the surgery.

When pars plana vitrectomy is combined with a scleral buckle and uses SF6 gas, studies have found that this combination can lead to better outcomes than vitrectomy alone, showing improved surgical success in certain situations.

Research on pars plana vitrectomy using perfluoropropane (C3F8) gas reported a 100% final reattachment rate in one group and 97.2% in another, demonstrating its effectiveness. These procedures generally did not present significant safety issues.

Studies also found that using a scleral buckle with C3F8 gas is safe and often leads to better results in more complicated cases.

Overall, these treatments are well-tolerated, have high success rates, and few complications, suggesting they are safe options for treating retinal detachment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for retinal detachment because they combine surgical techniques with innovative gas tamponade options that could improve patient outcomes. The use of sulfur hexafluoride and perfluoropropane gases is intended to enhance the reattachment process by providing longer-lasting support to the retina compared to air or other gases traditionally used. Additionally, integrating pars plana vitrectomy with scleral buckle offers a dual approach that might address more complex retinal detachment cases. These methods aim to provide more effective and potentially faster recovery for patients compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for retinal detachment?

Research has shown that the surgical techniques studied in this trial hold promise for treating retinal detachment, a condition where the retina separates from its underlying layer. One trial arm involves pars plana vitrectomy (PPV) with sulfur hexafluoride gas, achieving success in about 91% of cases. Another arm combines PPV with a scleral buckle and sulfur hexafluoride gas, potentially increasing success rates, particularly in more complex cases. Additionally, using perfluoropropane gas in PPV, studied in a separate arm, has a high success rate, with up to 97.4% of cases achieving reattachment. Another arm combines PPV with both a scleral buckle and perfluoropropane gas, demonstrating strong results and proving effective for reattaching the retina. Overall, these methods show high success rates in reattaching the retina and improving vision. ^{1 5 6 7 8}

Who Is on the Research Team?

Ali Dirani, MD MSc MPH

Principal Investigator

CHU de Québec - Université Laval

Mélanie Hébert, MD MSc

Principal Investigator

CHU de Québec - Université Laval

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a recent diagnosis of rhegmatogenous retinal detachment. It's not suitable for those with advanced proliferative vitreoretinopathy, long-standing detachments over 3 months old, or other complex eye conditions like severe diabetic retinopathy, macular holes, or history of certain eye surgeries.

Inclusion Criteria

I have been diagnosed with a type of retinal detachment.

Exclusion Criteria

I have a condition called retinopathy of prematurity.

I have had surgery for glaucoma or eye muscle alignment.

I have been diagnosed with acute retinal necrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo surgical repair of primary rhegmatogenous retinal detachment using pars plana vitrectomy with or without scleral buckle and gas tamponade

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored using multimodal imaging and quality of life questionnaires to assess surgical outcomes, visual outcomes, and complications

1 year

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Pars plana vitrectomy
• Pars plana vitrectomy with scleral buckle
• Perfluoropropane gas
• Sulfur hexafluoride gas tamponade

Trial Overview The study compares two surgical methods: pars plana vitrectomy (PPV) alone and PPV combined with scleral buckle. It also tests two types of gas tamponades used in surgery: sulfur hexafluoride (SF6) and perfluoropropane (C3F8). Patients are randomly assigned to one of the surgical techniques and one type of gas.

How Is the Trial Designed?

Group I: Pars plana vitrectomy with scleral buckle + sulfur hexafluoride gas tamponade Experimental Treatment 2 Interventions

Group II: Pars plana vitrectomy with scleral buckle + perfluoropropane gas tamponade Experimental Treatment 2 Interventions

Group III: Pars plana vitrectomy + perfluoropropane gas tamponade Experimental Treatment 2 Interventions

Group IV: Pars plana vitrectomy + sulfur hexafluoride gas tamponade Active Control 2 Interventions

Pars plana vitrectomy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hycamtin for:

• Ovarian cancer
• Small cell lung cancer
• Cervical cancer

Approved in United States as Hycamtin for:

• Ovarian cancer
• Small cell lung cancer
• Cervical cancer

Approved in Canada as Hycamtin for:

• Ovarian cancer
• Small cell lung cancer
• Cervical cancer

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Fighting Blindness Canada

Collaborator

Trials

1

Recruited

560+

Published Research Related to This Trial

In a study of 300 retinal detachment cases treated with pars plana vitrectomy, the use of supplemental scleral buckle decreased significantly from 53% in the first group to 17% in the third group, indicating a trend towards less reliance on this technique.

Despite the reduced use of scleral buckle, the single surgery reattachment rates remained high and stable across all groups (93% to 97%), suggesting that good anatomical and visual outcomes can be achieved with less frequent use of this adjunctive procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SUPPLEMENTAL SCLERAL BUCKLE IN THE ERA OF SMALL INCISION VITRECTOMY AND WIDE-ANGLE VIEWING SYSTEMS. Tabandeh, H., Khachaturov, A., Rezaei, KA., et al.[2021]

A systematic review of 8 studies involving 1612 eyes found that pars plana vitrectomy (PPV) combined with air tamponade has a similar primary treatment success rate and best-corrected visual acuity (BCVA) compared to PPV with gas tamponade for treating rhegmatogenous retinal detachment (RRD).

The air tamponade group experienced significantly lower mean intraocular pressure one day post-surgery and a reduced rate of epiretinal membrane development, indicating it may be a safer option with fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Air Tamponade in the Repair of Rhegmatogenous Retinal Detachment: A Systematic Review and Meta-Analysis. Zhu, A., Wu, J., Yuan, Y., et al.[2023]

In a review of 207 pars plana vitrectomy procedures, the combined vitrectomy-scleral buckle technique successfully reattached the retina in many cases, demonstrating its efficacy in treating retinal detachments complicated by vitreous pathology.

Patients who underwent this combined approach experienced significant visual improvement, highlighting the potential benefits of using either a one-handed or two-handed technique in these surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitrectomy in retinal detachment surgery. Shea, M., Siebert, LF.[2016]

In a study of 74 patients with primary noncomplex rhegmatogenous retinal detachment, both pars plana vitrectomy (PPV) and PPV combined with scleral buckle (PPV/SB) achieved similar rates of single surgery anatomical success, with 83% for PPV and 86% for PPV/SB, indicating that both methods are effective.

There were no significant differences in visual acuity improvement or anatomical success based on the type of surgery performed, suggesting that the addition of a scleral buckle does not provide additional benefits over PPV alone in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pars plana vitrectomy compared with pars plana vitrectomy combined with scleral buckle in the primary management of noncomplex rhegmatogenous retinal detachment. Orlin, A., Hewing, NJ., Nissen, M., et al.[2014]

In a study of 126 patients with rhegmatogenous retinal detachment (RRD) undergoing 25-gauge pars plana vitrectomy (PPV) with gas tamponade, the anatomical success rate was extremely high at 100%, with retinal attachment achieved in 125 eyes (99.2%) after a single operation.

The procedure also led to significant improvement in best corrected visual acuity (BCVA), with scores improving from an initial average of 0.89 logMar to 0.23 logMar by the end of the follow-up period, indicating effective restoration of vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

25-gauge vitrectomy and gas for the management of rhegmatogenous retinal detachment. Veith, M., Stranak, Z., Pencak, M., et al.[2019]

In a study of 28 patients with recurrent rhegmatogenous retinal detachment (RRD) associated with proliferative vitreoretinopathy (PVR), the single-procedure anatomic success rate of pars plana vitrectomy (PPV), retinectomy, and silicone oil tamponade was 85.2% at 3 months and 82.1% at 12 months, with a final reattachment rate of 100%.

Visual acuity improved slightly over 12 months, indicating that while the surgical technique is effective, the outcomes may depend on the preoperative condition of the macula and lens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PPV, Retinectomy, and Silicone Oil Without Scleral Buckle for Recurrent RRD From Proliferative Vitreoretinopathy. Deaner, JD., Aderman, CM., Bonafede, L., et al.[2020]

Internal gas tamponade, used without an episcleral buckle, is effective for treating certain types of retinal detachment, particularly when there are breaks in the superior half of the retina and no proliferative vitreoretinopathy.

The study compares the anatomical outcomes and complications of internal gas tamponade with and without vitrectomy, highlighting the safety and efficacy of these surgical techniques for first-time retinal detachment repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gas tamponade as a single technique in the treatment of retinal detachment: is vitrectomy needed? A comparative study of 120 cases. van Effenterre, G., Haut, J., Larricart, P., et al.[2022]

In a study of 65 patients with recurrent retinal detachment, combining pars plana vitrectomy (PPV) with scleral buckle (SB) significantly improved the rate of retinal reattachment (81.8% vs. 59.4% for PPV alone, p=0.047).

Despite worse preoperative visual acuity in the re-PPV+SB group, both groups achieved similar postoperative visual acuity, indicating that the addition of SB enhances anatomical success without compromising functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Combining Scleral Buckle Surgery with Pars Plana Vitrectomy for Treatment of Recurrent Retinal Detachment Secondary to Proliferative Vitreoretinopathy. Topcu, H., Erdogan, G., Alagoz, C., et al.[2023]

Pars plana vitrectomy (PPV) and the combined method of PPV with scleral buckle (SB) show significantly higher initial reattachment rates for uncomplicated pseudophakic retinal detachments compared to SB alone, with odds ratios of 1.69 and 3.54, respectively.

Patients undergoing PPV or the combined method are more likely to experience visual improvement, with odds ratios of 2.34 for PPV and 11.52 for the combined method, indicating better overall outcomes than those treated with SB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical management of pseudophakic retinal detachments: a meta-analysis. Arya, AV., Emerson, JW., Engelbert, M., et al.[2022]

In a study of 53 patients undergoing primary vitrectomy for complicated retinal detachments, retinal reattachment was achieved in 64% of cases after one operation and 92% after multiple operations, indicating a high success rate for this treatment method.

While primary vitrectomy showed promising anatomical success, it was associated with a high incidence of postoperative cataract formation in 86% of patients with a clear lens before surgery, highlighting a significant drawback of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment. Heimann, H., Bornfeld, N., Friedrichs, W., et al.[2022]

In a study of 20 patients with primary inferior rhegmatogenous retinal detachment, both PPV with silicone oil and scleral buckle and PPV with Oxane HD showed similar effectiveness, with 90% of retinas reattached at three months after oil removal.

The use of Oxane HD resulted in a significantly shorter operative time compared to silicone oil, suggesting it may be a more efficient option for this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxane HD vs silicone oil and scleral buckle in retinal detachment with proliferative vitreoretinopathy and inferior retinal breaks. Boscia, F., Furino, C., Recchimurzo, N., et al.[2021]

Citations

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

A Short-Time Real-World Study of Two Perfluoropropane ... The final retinal reattachment rates of the two groups were 100% and 97.2%, respectively, with no significant difference (p = 1.00). The gas configuration time, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002939406009093

Pars Plana Vitrectomy and Perfluoropropane (C3F8) ... The mean postoperative follow-up was 26.9 ± 16.5 months. The anatomical success rate after primary PPV and C3F8 tamponade was 63.2%. Regression analysis showed ...

3. nature.com nature.com/articles/s41598-024-79889-9

Thirteen year experience of vitrectomy and air tamponade ... The authors demonstrated air's safety in treating RRDs with a success rate of 88.5% for superior, inferior, and multiple breaks. More recently, ...

4. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-025-04271-w

Outcomes of perfluorocarbon liquid vs. posterior retinotomy as ... At 3 months postoperatively, retinal reattachment was achieved in 76% (22/29) of eyes in Group A vs. 66% (19/29) in Group B (χ2 = 0.75, p = ...

5. researchgate.net researchgate.net/publication/374648778_A_Short-Time_Real-World_Study_of_Two_Perfluoro_Propane_Tamponade_Methods_in_Pars_Plana_Vitrectomy_for_Retinal_Detachment

(PDF) A Short-Time Real-World Study of Two Perfluoro ... Results: The single-surgery retinal reattachment rates of the pure C3F8 group and mixed C3F8 group were 97.4% and 96.8%, respectively, with no ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002939424002095

Pars Plana Vitrectomy With Silicone Oil or Gas Tamponade ... Our results showed that gas tamponade yielded a significantly better final BCVA compared to silicone oil tamponade. This aligns with earlier studies that ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11577069/

Thirteen year experience of vitrectomy and air tamponade ... The authors demonstrated air's safety in treating RRDs with a success rate of 88.5% for superior, inferior, and multiple breaks. More recently, ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06927544

Intraocular Gas Tamponade for Treatment of Large ... The goal of this clinical trial is to evaluate the visual and anatomical outcomes of large (410-1000 μm) full-thickness macular holes repair surgery using ...