Rhegmatogenous Retinal DetachmentNCT05377606
Primary Vitrectomy With Silicone Oil or SF6 for Rhegmatogenous Retinal Detachment
A study testing Pars plana vitrectomy with silicone oil and Pars plana vitrectomy with SF6 in people with Rhegmatogenous Retinal Detachment and Primary Vitrectomy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment, Primary Vitrectomy
- What is being tested?
- Pars plana vitrectomy with silicone oil and Pars plana vitrectomy with SF6
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Dec 2021to 8 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary rhegmatogenous retinal detachment
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Macular Perfusion and Sensitivity Following Silicone Oil Tamponade Versus SF6 Gas for Primary 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).
Read more
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.
Read the detailed description
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.
- Being tested
- Pars plana vitrectomy with silicone oil, Pars plana vitrectomy with SF6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomy with silicone oilProcedure or surgery
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 SF6Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Pars plana vitrectomy with SF6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular perfusion - FAZ
Comparison of foveal avascular zone area between the different treatment arms as a measure of macular perfusion.
Measured: At 2 and 4 months following primary vitrectomy
Macular perfusion - SVP
Comparison of superficial retinal capillary vascular density between the different treatment arms.
Measured: At 2 and 4 months following primary vitrectomy
Macular perfusion - DVP
Comparison of deep retinal capillary vascular density between the different treatment arms.
Measured: At 2 and 4 months following primary vitrectomy
Secondary outcomes (4)
Macular sensitivity
Comparison of macular sensitivity between the different treatment arms using macular microperimetry.
Measured: At 2 and 4 months following primary vitrectomy
Thickness of ganglion cell complex
Comparison of the thickness of ganglion cell complex in microns between the different treatment arms using optical coherence tomography (OCT)
Measured: At 2 and 4 months following primary vitrectomy
Best corrected visual acuity
Comparison of best corrected visual acuity between the different treatment arms using standard Snellen charts.
Measured: At 2 and 4 months following primary vitrectomy
Retinal reattachment rate
Comparison of single-operation anatomical success (retinal reattachment) rate between the different treatment arms
Measured: At 4 months following primary vitrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start23 Dec 2021
- Primary completion8 Mar 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Safe Abdelmesih Abdelmalak, Cairo University
- Investigators
- Mina S. Abdelmalak, MSc, Principal investigator, Cairo UniversitySoheir M. Mahmoud, PhD, Study chair, Cairo UniversityAhmed A. Abdel Kader, PhD, Study director, Cairo UniversityAsmaa M. Shuaib, PhD, Study director, Cairo UniversityAyman G. Elnahry, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377606
- Sponsor's protocol ID
- MD-187-2021
- Status last verified
- Aug 2023
- First submitted
- 13 Feb 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be posted on clinicaltrials.gov when the study is concluded.
Publications
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.
PubMed 24978666Mitry 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.
PubMed 19515646Nielsen 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.
PubMed 32086859Barrie 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.
PubMed 12770985Vaziri 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.
PubMed 27041988Scheerlinck 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.
PubMed 29498239Ma 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.
PubMed 32209173Zhou 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.
PubMed 32571251Christensen 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.
PubMed 21914150Raczynska 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.
PubMed 30101697Newsom 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.
PubMed 15579983Goker 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.
PubMed 29304265Moharram 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.
PubMed 32021077Schwartz 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.
PubMed 32408387Abrams 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.
PubMed 9076205
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Perfusion and Sensitivity Following Silicone Oil Tamponade Versus SF6 Gas for Primary Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT05377606
- Acronym / sponsor ID
- MD-187-2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone oil group | Active comparator | Procedure: Pars plana vitrectomy with silicone oilPrimary 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). |
| Sulfur hexafluoride (SF6) group | Active comparator | Procedure: Pars plana vitrectomy with SF6Primary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary rhegmatogenous retinal detachment
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pars plana vitrectomy with silicone oilSilicone 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. | Procedure or surgery | Silicone oil group |
| Pars plana vitrectomy with SF6Sulfur 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. | Procedure or surgery | Sulfur hexafluoride (SF6) group |
Primary outcome
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.
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.
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.
4 secondary outcomes
Macular sensitivity
Time frame: At 2 and 4 months following primary vitrectomy
Thickness of ganglion cell complex
Time frame: At 2 and 4 months following primary vitrectomy
Best corrected visual acuity
Time frame: At 2 and 4 months following primary vitrectomy
Retinal reattachment rate
Time frame: At 4 months following primary vitrectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 24978666Hajari 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.
- Background: PubMed 19515646Mitry 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.
- Background: PubMed 32086859Nielsen 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.
- Background: PubMed 12770985Barrie 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.
- Background: PubMed 27041988Vaziri 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.
- Background: PubMed 29498239Scheerlinck 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.
- Background: PubMed 32209173Ma 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.
- Background: PubMed 32571251Zhou 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.
- Background: PubMed 21914150Christensen 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.
- Background: PubMed 30101697Raczynska 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.
- Background: PubMed 15579983Newsom 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.
- Background: PubMed 29304265Goker 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.
- Individual participant dataSharing planned: No. Results will be posted on clinicaltrials.gov when the study is concluded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mina S. Abdelmalak, MSc principal investigator
Cairo University
Soheir M. Mahmoud, PhD study chair
Cairo University
Ahmed A. Abdel Kader, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars plana vitrectomy with silicone oil and Pars plana vitrectomy with SF6 in people with Rhegmatogenous Retinal Detachment and Primary Vitrectomy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular perfusion - FAZ (time frame: At 2 and 4 months following primary vitrectomy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05377606, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.