Rhegmatogenous Retinal DetachmentNCT06324305
Comparative Study Between Three Different Techniques in Drainage of SRF During PPV in RRD
A study testing Pars plana vitrectomy (PPV) and drainage of subretinal fluid in people with Rhegmatogenous Retinal Detachment, run by Ain Shams University.
Trial summary
The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Pars plana vitrectomy (PPV) and drainage of subretinal fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to Apr 2025
- 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
- • Age: above 18 years old
- Patients with rhegmatogenous retinal detachment (RRD) where the detachment is involving the macula.
- Patients with proliferative vitreoretinopathy (PVR) no more than PVR -B.
- Patients with peripheral break.
- Duration of detachment: within one month.
Who cannot join
- • Patients with macula on RRD.
- Patients with tractional retinal detachment.
- Patients with giant retinal tear.
- Patients with proliferative vitreoretinopathy (PVR) more than PVR -B.
- More than one month duration of detachment.
- Patients with posterior staphyloma.
- Patients with recurrent retinal detachment.
- Patients with full thickness macular hole.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Three Different Techniques in Drainage of Sub-Retinal Fluid During Pars Plana Vitrectomy for Patients With Macula Off Rhegmatogenous Retinal Detachment
The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent sub-retnal fluid and related intra or postoperative complications
Read the detailed description
Rhegmatogenous retinal detachment (RRD) is a serious surgical condition with significant ocular morbidity if not managed properly. Approaches to the repair of RRD have greatly evolved over the years, leading to outstanding primary surgical success rates. The management of RRD is often a topic of great debate. Several factors may affect surgical success and dictate a surgeon's preference for the technique employed.
Scleral buckling, vitrectomy and pneumatic retinopexy have been used successfully for the treatment of RRD.
Using original breaks to drain subretinal fluid without perfluorocarbon liquid in cases of vitrectomy for RRD may be an effective and safe surgical technique for functional and anatomical recovery without serious complications. but it may leave some SRF at the macula (2) Posterior drainage retinotomy is a surgical technique that involves the creation of a small retinal hole to facilitate the removal of subretinal fluid (SRF), in conjunction with pars plana vitrectomy (PPV), for the treatment of rhegmatogenous retinal detachment (RRD) (3). First described by Machemer in 1981 as a technique for relaxing the retina in proliferative vitreoretinopathy (PVR) and trauma (4), retinotomy has since expanded to include more indications for its use (5). In addition, the use of drainage retinotomy aids the management of bullous RRD, because the complete drainage of fluid significantly decreases the likelihood of retinal fold formation (6). Although there are benefits with retinotomy, complications associated with its use include visual field scotomas and PVR at the endodrainage retinotomy sites .
Perfluorocarbon liquid (PFC) has been a major milestone in vitrectomy surgery and is an invaluable tool in the repair of giant retinal tear-associated detachments (8). By stabilizing the mobile, detached retina, PFC reduces the risk of iatrogenic breaks, especially towards the periphery. PFC may also be useful to assist with subretinal fluid drainage in cases when the retinal break is anterior in order to avoid the need for a posterior drainage retinotomy.
Subretinal fluid that persists after pars plana vitrectomy for RRD is defined by being persistent for more than one month. While mostly benign, SRF has been shown to exhibit complications. Those include the development of macular hole (MH), permanent disruption of the outer retinal layers, subretinal fibrosis, macular edema, and epiretinal membranes affecting the visual outcome.
To the best of our knowledge, very limited reports studied the comparison between the three techniques in an anatomical along with a functional way, presence of subretinal fluid that persists after (PPV) for macula off RRD, or related intra and postoperative complications and also relating them to the functional outcome.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Pars plana vitrectomy (PPV) and drainage of subretinal fluid
- Keywords
- drainage techniquies, comparison, subretinal fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomy (PPV) and drainage of subretinal fluidProcedure or surgery
Drainage of subretinal fluid during Pars Plana Vitrectomy in patients with rhegmatogenous retinal detachment (RRD)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | drainage of sub-retinal fluid from the original (primary) break Receives: Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid |
| Group 2 | Active comparator | drainage of sub-retinal fluid using perfluorocarbon (PFC) and removing sub-retinal fluid through the original break or peripheral retinotomy Receives: Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid |
| Group 3 | Active comparator | drainage of sub-retinal fluid through formation of a posterior drainage retinotomy only. Receives: Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV)
optical coherence tomography (OCT) imaging after PPV
Measured: within 1 week and within 1 month from the PPV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina tarek mohamed kamel, Ain Shams University
- Investigators
- Dina T Mohamed, master's, Principal investigator, AinShams UniversityTamer F Elewa, MD, Study chair, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324305
- Sponsor's protocol ID
- SRF drainage techniques in RRD
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Warren A, Wang DW, Lim JI. Rhegmatogenous retinal detachment surgery: A review. Clin Exp Ophthalmol. 2023 Apr;51(3):271-279. doi: 10.1111/ceo.14205. Epub 2023 Jan 25.
PubMed 36640144Fu Y, Chen S, Gu ZH, Zhang YL, Li LY, Yang N. Natural history of persistent subretinal fluid following the successful repair of rhegmatogenous retinal detachment. Int J Ophthalmol. 2020 Oct 18;13(10):1621-1628. doi: 10.18240/ijo.2020.10.17. eCollection 2020.
PubMed 33078114Mimouni M, Jaouni T, Ben-Yair M, Almus S, Derman L, Ehrenberg S, Almeida D, Barak Y, Zayit-Soudry S, Averbukh E. PERSISTENT LOCULATED SUBRETINAL FLUID AFTER RHEGMATOGENOUS RETINAL DETACHMENT SURGERY. Retina. 2020 Jun;40(6):1153-1159. doi: 10.1097/IAE.0000000000002565.
PubMed 31241497Chen X, Zhang Y, Yan Y, Hong L, Zhu L, Deng J, Din Q, Huang Z, Zhou H. COMPLETE SUBRETINAL FLUID DRAINAGE IS NOT NECESSARY DURING VITRECTOMY SURGERY FOR MACULA-OFF RHEGMATOGENOUS RETINAL DETACHMENT WITH PERIPHERAL BREAKS: A Prospective, Nonrandomized Comparative Interventional Study. Retina. 2017 Mar;37(3):487-493. doi: 10.1097/IAE.0000000000001180.
PubMed 27429377
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Three Different Techniques in Drainage of Sub-Retinal Fluid During Pars Plana Vitrectomy for Patients With Macula Off Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT06324305
- Acronym / sponsor ID
- SRF drainage techniques in RRD
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- drainage techniquies, comparison, subretinal fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 21 Mar 2024 (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.
The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent sub-retnal fluid and related intra or postoperative complications
Detailed description
Rhegmatogenous retinal detachment (RRD) is a serious surgical condition with significant ocular morbidity if not managed properly. Approaches to the repair of RRD have greatly evolved over the years, leading to outstanding primary surgical success rates. The management of RRD is often a topic of great debate. Several factors may affect surgical success and dictate a surgeon's preference for the technique employed.
Scleral buckling, vitrectomy and pneumatic retinopexy have been used successfully for the treatment of RRD.
Using original breaks to drain subretinal fluid without perfluorocarbon liquid in cases of vitrectomy for RRD may be an effective and safe surgical technique for functional and anatomical recovery without serious complications. but it may leave some SRF at the macula (2) Posterior drainage retinotomy is a surgical technique that involves the creation of a small retinal hole to facilitate the removal of subretinal fluid (SRF), in conjunction with pars plana vitrectomy (PPV), for the treatment of rhegmatogenous retinal detachment (RRD) (3). First described by Machemer in 1981 as a technique for relaxing the retina in proliferative vitreoretinopathy (PVR) and trauma (4), retinotomy has since expanded to include more indications for its use (5). In addition, the use of drainage retinotomy aids the management of bullous RRD, because the complete drainage of fluid significantly decreases the likelihood of retinal fold formation (6). Although there are benefits with retinotomy, complications associated with its use include visual field scotomas and PVR at the endodrainage retinotomy sites .
Perfluorocarbon liquid (PFC) has been a major milestone in vitrectomy surgery and is an invaluable tool in the repair of giant retinal tear-associated detachments (8). By stabilizing the mobile, detached retina, PFC reduces the risk of iatrogenic breaks, especially towards the periphery. PFC may also be useful to assist with subretinal fluid drainage in cases when the retinal break is anterior in order to avoid the need for a posterior drainage retinotomy.
Subretinal fluid that persists after pars plana vitrectomy for RRD is defined by being persistent for more than one month. While mostly benign, SRF has been shown to exhibit complications. Those include the development of macular hole (MH), permanent disruption of the outer retinal layers, subretinal fibrosis, macular edema, and epiretinal membranes affecting the visual outcome.
To the best of our knowledge, very limited reports studied the comparison between the three techniques in an anatomical along with a functional way, presence of subretinal fluid that persists after (PPV) for macula off RRD, or related intra and postoperative complications and also relating them to the functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluiddrainage of sub-retinal fluid from the original (primary) break |
| Group 2 | Active comparator | Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluiddrainage of sub-retinal fluid using perfluorocarbon (PFC) and removing sub-retinal fluid through the original break or peripheral retinotomy |
| Group 3 | Active comparator | Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluiddrainage of sub-retinal fluid through formation of a posterior drainage retinotomy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Age: above 18 years old
Key exclusion criteria (8 listed)
- • Patients with macula on RRD.
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 (PPV) and drainage of subretinal fluidDrainage of subretinal fluid during Pars Plana Vitrectomy in patients with rhegmatogenous retinal detachment (RRD) | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV)
Time frame: within 1 week and within 1 month from the PPV
optical coherence tomography (OCT) imaging after PPV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 36640144Warren A, Wang DW, Lim JI. Rhegmatogenous retinal detachment surgery: A review. Clin Exp Ophthalmol. 2023 Apr;51(3):271-279. doi: 10.1111/ceo.14205. Epub 2023 Jan 25.
- Background: PubMed 33078114Fu Y, Chen S, Gu ZH, Zhang YL, Li LY, Yang N. Natural history of persistent subretinal fluid following the successful repair of rhegmatogenous retinal detachment. Int J Ophthalmol. 2020 Oct 18;13(10):1621-1628. doi: 10.18240/ijo.2020.10.17. eCollection 2020.
- Background: PubMed 31241497Mimouni M, Jaouni T, Ben-Yair M, Almus S, Derman L, Ehrenberg S, Almeida D, Barak Y, Zayit-Soudry S, Averbukh E. PERSISTENT LOCULATED SUBRETINAL FLUID AFTER RHEGMATOGENOUS RETINAL DETACHMENT SURGERY. Retina. 2020 Jun;40(6):1153-1159. doi: 10.1097/IAE.0000000000002565.
- Background: PubMed 27429377Chen X, Zhang Y, Yan Y, Hong L, Zhu L, Deng J, Din Q, Huang Z, Zhou H. COMPLETE SUBRETINAL FLUID DRAINAGE IS NOT NECESSARY DURING VITRECTOMY SURGERY FOR MACULA-OFF RHEGMATOGENOUS RETINAL DETACHMENT WITH PERIPHERAL BREAKS: A Prospective, Nonrandomized Comparative Interventional Study. Retina. 2017 Mar;37(3):487-493. doi: 10.1097/IAE.0000000000001180.
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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.
Dina T Mohamed, master's principal investigator
AinShams University
Tamer F Elewa, MD study chair
AinShams University
Questions about this trial
What is this clinical trial studying?
A study testing Pars plana vitrectomy (PPV) and drainage of subretinal fluid in people with Rhegmatogenous Retinal Detachment, run by Ain Shams University.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina T Mohamed, master's (01067747874, dina.tarek@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV) (time frame: within 1 week and within 1 month from the PPV). 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 NCT06324305, which also lists 4 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 21 Mar 2024.