Primary Vitrectomy With Silicone Oil or SF6 for Rhegmatogenous Retinal Detachment

NCT05377606 | Completed

• 1 other identifier: MD-187-2021
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhegmatogenous Retinal Detachment; Primary Vitrectomy

Outcome Measures

Primary Outcomes (3)

• Macular perfusion - FAZ

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

  At 2 and 4 months following primary vitrectomy

• Macular perfusion - SVP

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

  At 2 and 4 months following primary vitrectomy

• Macular perfusion - DVP

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

  At 2 and 4 months following primary vitrectomy

Secondary Outcomes (4)

• Macular sensitivity

  At 2 and 4 months following primary vitrectomy

• Thickness of ganglion cell complex

  At 2 and 4 months following primary vitrectomy

• Best corrected visual acuity

  At 2 and 4 months following primary vitrectomy

• Retinal reattachment rate

  At 4 months following primary vitrectomy

Study Arms (2)

Silicone oil group

ACTIVE COMPARATOR

Primary pars plana vitrectomy will be performed and silicone oil will be used as the tamponading agent. For these patients, optical coherence tomography (OCT) and angiography (OCTA), along with microperimetry will be done 2 months after the primary surgery. Then they will be scheduled for silicone oil removal after 3 months from the time of primary surgery. Finally, the OCT, OCTA, and microperimetry will be repeated once more after 4 months from the vitrectomy (i.e. one month after the silicone oil removal).

Procedure: Pars plana vitrectomy with silicone oil

Sulfur hexafluoride (SF6) group

ACTIVE COMPARATOR

Primary pars plana vitrectomy will be performed and sulfur hexafluoride (SF6) will be used as the tamponading agent. For these patients, optical coherence tomography (OCT) and angiography (OCTA), along with microperimetry will be done 2 months and 4 months after the primary surgery.

Procedure: Pars plana vitrectomy with SF6

Interventions

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.

Silicone oil group

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.

Sulfur hexafluoride (SF6) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary rhegmatogenous retinal detachment

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, 11956, Egypt

Location

Related Publications (16)

• Hajari JN, Bjerrum SS, Christensen U, Kiilgaard JF, Bek T, la Cour M. A nationwide study on the incidence of rhegmatogenous retinal detachment in Denmark, with emphasis on the risk of the fellow eye. Retina. 2014 Aug;34(8):1658-65. doi: 10.1097/IAE.0000000000000104.

  PMID: 24978666 BACKGROUND

• Mitry D, Charteris DG, Fleck BW, Campbell H, Singh J. The epidemiology of rhegmatogenous retinal detachment: geographical variation and clinical associations. Br J Ophthalmol. 2010 Jun;94(6):678-84. doi: 10.1136/bjo.2009.157727. Epub 2009 Jun 9.

  PMID: 19515646 BACKGROUND

• Nielsen BR, Alberti M, Bjerrum SS, la Cour M. The incidence of rhegmatogenous retinal detachment is increasing. Acta Ophthalmol. 2020 Sep;98(6):603-606. doi: 10.1111/aos.14380. Epub 2020 Feb 21.

  PMID: 32086859 BACKGROUND

• Barrie T. Debate overview. Repair of a primary rhegmatogenous retinal detachment. Br J Ophthalmol. 2003 Jun;87(6):790. doi: 10.1136/bjo.87.6.790. No abstract available.

  PMID: 12770985 BACKGROUND

• Vaziri K, Schwartz SG, Kishor KS, Flynn HW Jr. Tamponade in the surgical management of retinal detachment. Clin Ophthalmol. 2016 Mar 16;10:471-6. doi: 10.2147/OPTH.S98529. eCollection 2016.

  PMID: 27041988 BACKGROUND

• Scheerlinck LM, Schellekens PA, Liem AT, Steijns D, van Leeuwen R. Retinal sensitivity following intraocular silicone oil and gas tamponade for rhegmatogenous retinal detachment. Acta Ophthalmol. 2018 Sep;96(6):641-647. doi: 10.1111/aos.13685. Epub 2018 Mar 2.

  PMID: 29498239 BACKGROUND

• Ma Y, Zhu XQ, Peng XY. Macular Perfusion Changes and Ganglion Cell Complex Loss in Patients with Silicone Oil-related Visual Loss. Biomed Environ Sci. 2020 Mar 20;33(3):151-157. doi: 10.3967/bes2020.021.

  PMID: 32209173 BACKGROUND

• Zhou Y, Zhang S, Zhou H, Gao M, Liu H, Sun X. Comparison of fundus changes following silicone oil and sterilized air tamponade for macular-on retinal detachment patients. BMC Ophthalmol. 2020 Jun 22;20(1):249. doi: 10.1186/s12886-020-01523-9.

  PMID: 32571251 BACKGROUND

• Christensen UC, la Cour M. Visual loss after use of intraocular silicone oil associated with thinning of inner retinal layers. Acta Ophthalmol. 2012 Dec;90(8):733-7. doi: 10.1111/j.1755-3768.2011.02248.x. Epub 2011 Sep 13.

  PMID: 21914150 BACKGROUND

• Raczynska D, Mitrosz K, Raczynska K, Glasner L. The Influence of Silicone Oil on the Ganglion Cell Complex After Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment. Curr Pharm Des. 2018 Dec 8;24(29):3476-3493. doi: 10.2174/1381612824666180813115438.

  PMID: 30101697 BACKGROUND

• Newsom RS, Johnston R, Sullivan PM, Aylward GB, Holder GE, Gregor ZJ. Sudden visual loss after removal of silicone oil. Retina. 2004 Dec;24(6):871-7. doi: 10.1097/00006982-200412000-00005.

  PMID: 15579983 BACKGROUND

• Goker YS, Yuksel K, Turan MF, Sonmez K, Tekin K, Yilmazbas P. Segmental Analysis of Macular Layers in Patients With Rhegmatogenous Retinal Detachment Treated With Perfluoropropane or Silicon Oil. Ophthalmic Surg Lasers Imaging Retina. 2018 Jan 1;49(1):41-47. doi: 10.3928/23258160-20171215-06.

  PMID: 29304265 BACKGROUND

• Moharram HM, Abdelhalim AS, Hamid MA, Abdelkader MF. Comparison Between Silicone Oil and Gas in Tamponading Giant Retinal Breaks. Clin Ophthalmol. 2020 Jan 15;14:127-132. doi: 10.2147/OPTH.S237783. eCollection 2020.

  PMID: 32021077 BACKGROUND

• Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.

  PMID: 32408387 BACKGROUND

• Abrams GW, Azen SP, McCuen BW 2nd, Flynn HW Jr, Lai MY, Ryan SJ. Vitrectomy with silicone oil or long-acting gas in eyes with severe proliferative vitreoretinopathy: results of additional and long-term follow-up. Silicone Study report 11. Arch Ophthalmol. 1997 Mar;115(3):335-44. doi: 10.1001/archopht.1997.01100150337005.

  PMID: 9076205 BACKGROUND

• Krzystolik MG, D'Amico DJ. Complications of intraocular tamponade: silicone oil versus intraocular gas. Int Ophthalmol Clin. 2000 Winter;40(1):187-200. doi: 10.1097/00004397-200040010-00018. No abstract available.

  PMID: 10713925 BACKGROUND

MeSH Terms

Interventions

Silicone Oils

Intervention Hierarchy (Ancestors)

Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mina S. Abdelmalak, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

• Soheir M. Mahmoud, PhD

  Cairo University

  STUDY CHAIR

• Ahmed A. Abdel Kader, PhD

  Cairo University

  STUDY DIRECTOR

• Asmaa M. Shuaib, PhD

  Cairo University

  STUDY DIRECTOR

• Ayman G. Elnahry, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Surgeon will be masked to the tamponading agent (silicone oil or gas) till the end of the operation when either agent will be injected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: May 17, 2022
• Study Start: December 23, 2021
• Primary Completion: March 8, 2023
• Study Completion: May 8, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)