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Primary Vitrectomy With Silicone Oil or SF6 for Rhegmatogenous Retinal Detachment

Primary Purpose

Rhegmatogenous Retinal Detachment, Primary Vitrectomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pars plana vitrectomy with silicone oil
Pars plana vitrectomy with SF6
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Silicone oil group

Sulfur hexafluoride (SF6) group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Macular perfusion - FAZ
Comparison of foveal avascular zone area between the different treatment arms as a measure of macular perfusion.
Macular perfusion - SVP
Comparison of superficial retinal capillary vascular density between the different treatment arms.
Macular perfusion - DVP
Comparison of deep retinal capillary vascular density between the different treatment arms.

Secondary Outcome Measures

Macular sensitivity
Comparison of macular sensitivity between the different treatment arms using macular microperimetry.
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)
Best corrected visual acuity
Comparison of best corrected visual acuity between the different treatment arms using standard Snellen charts.
Retinal reattachment rate
Comparison of single-operation anatomical success (retinal reattachment) rate between the different treatment arms

Full Information

First Posted
February 13, 2022
Last Updated
August 29, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05377606
Brief Title
Primary Vitrectomy With Silicone Oil or SF6 for Rhegmatogenous Retinal Detachment
Official Title
Macular Perfusion and Sensitivity Following Silicone Oil Tamponade Versus SF6 Gas for Primary Rhegmatogenous Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
March 8, 2023 (Actual)
Study Completion Date
May 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment, Primary Vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Surgeon will be masked to the tamponading agent (silicone oil or gas) till the end of the operation when either agent will be injected.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silicone oil group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Sulfur hexafluoride (SF6) group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy with silicone oil
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy with SF6
Intervention Description
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 Outcome Measure Information:
Title
Macular perfusion - FAZ
Description
Comparison of foveal avascular zone area between the different treatment arms as a measure of macular perfusion.
Time Frame
At 2 and 4 months following primary vitrectomy
Title
Macular perfusion - SVP
Description
Comparison of superficial retinal capillary vascular density between the different treatment arms.
Time Frame
At 2 and 4 months following primary vitrectomy
Title
Macular perfusion - DVP
Description
Comparison of deep retinal capillary vascular density between the different treatment arms.
Time Frame
At 2 and 4 months following primary vitrectomy
Secondary Outcome Measure Information:
Title
Macular sensitivity
Description
Comparison of macular sensitivity between the different treatment arms using macular microperimetry.
Time Frame
At 2 and 4 months following primary vitrectomy
Title
Thickness of ganglion cell complex
Description
Comparison of the thickness of ganglion cell complex in microns between the different treatment arms using optical coherence tomography (OCT)
Time Frame
At 2 and 4 months following primary vitrectomy
Title
Best corrected visual acuity
Description
Comparison of best corrected visual acuity between the different treatment arms using standard Snellen charts.
Time Frame
At 2 and 4 months following primary vitrectomy
Title
Retinal reattachment rate
Description
Comparison of single-operation anatomical success (retinal reattachment) rate between the different treatment arms
Time Frame
At 4 months following primary vitrectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina S. Abdelmalak, MSc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soheir M. Mahmoud, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed A. Abdel Kader, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Asmaa M. Shuaib, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayman G. Elnahry, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Cairo University
City
Cairo
ZIP/Postal Code
11956
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be posted on clinicaltrials.gov when the study is concluded.
Citations:
PubMed Identifier
24978666
Citation
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Results Reference
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Results Reference
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Citation
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Results Reference
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Citation
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Primary Vitrectomy With Silicone Oil or SF6 for Rhegmatogenous Retinal Detachment

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