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

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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for retinal detachment?

Research shows that combining pars plana vitrectomy (a surgery to remove the gel-like substance in the eye) with a scleral buckle (a band placed around the eye) can successfully reattach the retina and improve vision in many cases. Additionally, using gas tamponade (a bubble of gas to hold the retina in place) during vitrectomy has been effective in managing certain types of retinal detachment. ^{1 2 3 4 5}

Is the combination of surgical techniques and gas tamponade for retinal detachment generally safe for humans?

The research indicates that surgical techniques like pars plana vitrectomy, with or without scleral buckle, and the use of gas tamponade, have been studied for retinal detachment. These procedures are generally considered safe, but as with any surgery, there are risks involved, and outcomes can vary depending on the specific condition and patient. ^{1 5 6 7 8}

How does the treatment of pars plana vitrectomy with scleral buckle differ from other treatments for retinal detachment?

Pars plana vitrectomy with scleral buckle is unique because it combines two surgical techniques: removing the vitreous gel from the eye (vitrectomy) and adding a supportive band around the eye (scleral buckle) to help reattach the retina. This combination is particularly useful for more complex cases of retinal detachment, offering a more comprehensive approach compared to using either technique alone. ^{4 7 9 10 11}

What is the purpose of this trial?

Background: Few large randomized controlled trials provide strong evidence to guide surgical repair of primary rhegmatogenous retinal detachment (RRD) repair. The purpose of this factorial, single-blind, randomized controlled trial is to analyze and compare the surgical outcomes, functional visual outcomes, complications, and quality of life associated with RRD repair using (A) pars plana vitrectomy only (PPV) or PPV with scleral buckle (PPV-SB) and (B) sulfur hexafluoride gas (SF6) or perfluoropropane gas (C3F8) tamponade. Methods: Eligible patients with moderately complex RRD will be randomized 1:1 to PPV or PPV-SB and 1:1 to SF6 or C3F8 gas tamponade. Approximately 560 patients will be recruited to be able to detect a difference of around 10% in SSAS rate between groups. Patients will be followed using multimodal imaging and quality of life questionnaires before and after the surgical repair until 1 year postoperative. The primary outcome will be single surgery anatomic success (SSAS), defined as absence of reoperation for recurrent RRD in the operating room. Secondary outcomes will be pinhole visual acuity (PHVA) at 8-10 weeks and 6 months, final best-corrected visual acuity (BCVA), final retina status (i.e., attached or detached), time to onset of RRD recurrence, severity and number of complications, and questionnaire results. Discussion: This will be the first 2 × 2 factorial randomized controlled trial examining repair techniques in primary RRD. It will also be the first randomized controlled trial to compare gas tamponade between the two most common agents. Notably, it will be adequately powered to detect a clinically significant effect size. The use of multimodal imaging will also be a novel aspect of this study, allowing us to compare head-to-head the impact of adding an SB to the retina's recovery after RRD repair and of differing gas tamponades. Until now, the treatment of RRD has been largely guided by pragmatic retrospective cohort studies. There is a lack of strong evidence guiding therapeutic decisions and this trial will address (1) whether supplemental SB is justified and (2) whether longer duration gas tamponade with C3F8 is necessary.

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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]

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 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]

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]

References

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

SUPPLEMENTAL SCLERAL BUCKLE IN THE ERA OF SMALL INCISION VITRECTOMY AND WIDE-ANGLE VIEWING SYSTEMS. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Vitrectomy in retinal detachment surgery. [2016]

3. Turkey 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. [2023]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

25-gauge vitrectomy and gas for the management of rhegmatogenous retinal detachment. [2019]

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

Surgical management of pseudophakic retinal detachments: a meta-analysis. [2022]

6. United States 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. [2014]

7. Germany pubmed.ncbi.nlm.nih.gov

Primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Oxane HD vs silicone oil and scleral buckle in retinal detachment with proliferative vitreoretinopathy and inferior retinal breaks. [2021]

9. Germany 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. [2022]

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

PPV, Retinectomy, and Silicone Oil Without Scleral Buckle for Recurrent RRD From Proliferative Vitreoretinopathy. [2020]

11. Switzerland 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. [2023]