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Completed

NCT Number: NCT05377606

Primary Vitrectomy With Silicone Oil or SF6 for Rhegmatogenous Retinal Detachment

Rhegmatogenous retinal detachment (RRD) is the separation of the neurosensory retina from the retinal pigment epithelium caused by the presence of a break that leads to the passage of fluid from the vitreous cavity into the potential subretinal space. It is a sight threatening disease, affecting largely people 50 years or older, with an annual incidence varying between 6.3 and 17.9 people per 100,000 population, and is unfortunately increasing. Although other surgical options do exist for the repair of primary RRD, pars plana vitrectomy (PPV) has clear advantages and is certainly effective in the treatment of these patients.

Several agents are used for intraocular tamponade following PPV for RRD. These agents are either silicone oil (SO) or gases like air, perfluoropropane (C3F8), sulfur hexafluoride (SF6), or perfluoroethane (C2F6).

In addition to the complications uniquely peculiar to using SO, research has found out that a reduction in retinal sensitivity on microperimetry was greater in SO tamponade in comparison with gas, as well as poorer visual outcome, microvasculature damage and affection of retinal layers including ganglion cell complex (GCC) in the SO group.

Even though many studies were done to compare between SO and intraocular gas tamponades with respect to many aspects, only one study compared the effects SO had on macular vasculature and anatomy in comparison with air and no study at all to date has compared the SO to SF6 gas in terms of retinal vascular changes, correlating them to thinning of GCC and macular sensitivity, which is precisely the main aim of the current study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Cairo University

Cairo, 11956, Egypt

About this study

Rhegmatogenous retinal detachment (RRD) is the separation of the neurosensory retina from the retinal pigment epithelium (RPE) caused by the presence of a break that leads to the passage of fluid from the vitreous cavity into the potential subretinal space. It is a sight threatening disease, affecting largely people 50 years or older, with an annual incidence varying between 6.3 and 17.9 people per 100,000 population, and is unfortunately increasing. Although other surgical options do exist for the repair of primary RRD, viz. scleral buckling and pneumatic retinopexy, primary pars plana vitrectomy (PPV) has clear advantages and is certainly effective in the treatment of these patients, with a primary success rate of 85%, making it the leading management modality.

Several agents are used for intraocular tamponade following PPV for RRD, in order to provide surface tension across the retinal breaks thus preventing the ingress once more of fluid into the subretinal space, giving time for the permanent seal provided by the retinopexy done whether photocoagulation or cryopexy. These agents are either silicone oil (SO) or gases like air, perfluoropropane (C3F8), sulfur hexafluoride (SF6), or perfluoroethane (C2F6).

In addition to the complications uniquely peculiar to using SO, research has found out that a reduction in retinal sensitivity on microperimetry was greater in SO tamponade in comparison with gas, as well as poorer visual outcome, microvasculature damage and affection of retinal layers including ganglion cell complex (GCC) in the former group leading to the so-called Silicone Oil-Related Visual Loss (SORVL).

Even though many studies were done to compare between SO and intraocular gas tamponades with respect to many aspects, only one study by Zhou et al in 2020 compared the effects SO endotamponade had on macular vasculature and anatomy in comparison with sterilized air tamponade and no study at all to date has compared the SO to SF6 gas in terms of retinal vascular changes, correlating them to thinning of GCC and macular sensitivity, which is precisely the main aim of the current study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary rhegmatogenous retinal detachment

Exclusion criteria

  • Macula-on retinal detachment
  • Change of decision of type of endotamponade used intraoperatively
  • Giant retinal tear
  • Proliferative vitreoretinopathy worse than grade B
  • Recent lens surgery within the previous 3 months prior to presentation
  • Prior vitreoretinal surgery
  • Macular hole
  • Signs of epiretinal membrane
  • Diabetic retinopathy
  • Macular degeneration or other macular disorders
  • Inferior retinal breaks between 4 and 8 o'clock
  • History of uveitis
  • History of glaucoma

Treatment and study plan

Pars plana vitrectomy with silicone oil

Procedure

Silicone oil will be used at the end of primary vitrectomy. OCT, OCTA and microperimetry will be done 2 months later. Silicone oil will be removed at 3 months. Finally, the OCT, OCTA, and microperimetry will be repeated once more after 4 months from the vitrectomy.

Pars plana vitrectomy with SF6

Procedure

Sulfur hexafluoride (SF6) will be used at the end of primary vitrectomy. OCT, OCTA, and microperimetry will be done 2 months and 4 months after surgery.

Primary outcomes

  1. Macular perfusion - FAZ

    Time frame: At 2 and 4 months following primary vitrectomy

    Comparison of foveal avascular zone area between the different treatment arms as a measure of macular perfusion.

  2. Macular perfusion - SVP

    Time frame: At 2 and 4 months following primary vitrectomy

    Comparison of superficial retinal capillary vascular density between the different treatment arms.

  3. Macular perfusion - DVP

    Time frame: At 2 and 4 months following primary vitrectomy

    Comparison of deep retinal capillary vascular density between the different treatment arms.

Secondary outcomes

  1. Macular sensitivity

    Time frame: At 2 and 4 months following primary vitrectomy

    Comparison of macular sensitivity between the different treatment arms using macular microperimetry.

  2. Thickness of ganglion cell complex

    Time frame: At 2 and 4 months following primary vitrectomy

    Comparison of the thickness of ganglion cell complex in microns between the different treatment arms using optical coherence tomography (OCT)

  3. Best corrected visual acuity

    Time frame: At 2 and 4 months following primary vitrectomy

    Comparison of best corrected visual acuity between the different treatment arms using standard Snellen charts.

  4. Retinal reattachment rate

    Time frame: At 4 months following primary vitrectomy

    Comparison of single-operation anatomical success (retinal reattachment) rate between the different treatment arms

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Macular Perfusion and Sensitivity Following Silicone Oil Tamponade Versus SF6 Gas for Primary Rhegmatogenous Retinal Detachment

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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