Rhegmatogenous Retinal DetachmentNCT06919211
Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for Rhegmatogenous Retinal Detachment
A study testing Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment in people with Rhegmatogenous Retinal Detachment, run by Benha University at 1 site in Egypt.
Trial summary
Purpose To evaluate the outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications. 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?
- Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 30 Jul 2024
- 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
- A clear diagnosis of primary RRD requiring surgery, 18 years or older, The potential to return for follow-up visits for at least 6 months post-surgery.
Who cannot join
- When presented with tractional or exudative retinal detachment, had surgery on the affected eye in the past, presented with severe eye disorders like advanced glaucoma or endophthalmitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment
Purpose To evaluate the outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications.
Methods This is a prospective randomized controlled trial that included 58 eyes with RRD, divided into Group A (PFCL, n = 29) and Group B (PR, n = 29). Preoperative assessments included best-corrected visual acuity (BCVA), IOP, axial length, lens status, macula status, and PVR grade. Outcomes were evaluated at 1 week, 1 month, 2 months, and 3 months postoperatively. Primary outcomes included retinal reattachment rates and the number of operations; secondary outcomes included BCVA, IOP changes, complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal DetachmentProcedure or surgery
This study compares outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications
| Study group | Role | What they receive |
|---|---|---|
| Perfluorocarbon Liquid Group | Experimental | Not described Receives: Procedure: Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment |
| Posterior Retinotomy Group | Experimental | Not described Receives: Procedure: Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal reattachment rates
Measured: One month, Two months, and Three Months
Number of operations
Measured: One month, Two months, and Three Monthes
Secondary outcomes (3)
Best-corrected visual acuity (BCVA)
Measured: One month, Two months, and Three Monthes
Intraocular pressure (IOP)
Measured: One month, Two months, and Three Monthes
Complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success
Measured: One month, Two months, and Three Monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Jan 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Benha 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919211
- Sponsor's protocol ID
- Ophth._20/2024Med.Research
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vo LV, Ryan EH, Ryan CM, Shah GK, Gupta OP, Capone A Jr, Eliott D, Yonekawa Y, Bhavsar AR, Emerson MV, Jones JM, Emerson GG. Posterior Retinotomy vs Perfluorocarbon Liquid to Aid Drainage of Subretinal Fluid During Primary Rhegmatogenous Retinal Detachment Repair (PRO Study Report No. 10). J Vitreoretin Dis. 2020 Aug 12;4(6):494-498. doi: 10.1177/2474126420941372. eCollection 2020 Nov-Dec.
PubMed 37007660Vidne O, Blum Meirovitch S, Rabina G, Abd Eelkader A, Prat D, Barequet D, Moisseiev J, Moisseiev E. Perfluorocarbon Liquid Vs. Subretinal Fluid Drainage during Vitrectomy for the Primary Repair of Rhegmatogenous Retinal Detachment: A Comparative Study. Curr Eye Res. 2018 Nov;43(11):1389-1394. doi: 10.1080/02713683.2018.1490436. Epub 2018 Jul 9.
PubMed 29912572Mohamed Elsayed Saad E, Elbadry Mohammed Mohammed H, Mohamed-Aly Ibrahim M, Hassan Salama Selim O, Mostafa Elsayed Abdelhafeez S, Mohammed Sakr A, Mohamed Abo Elftouh Elsalhy F, Abdelmohsen Ali Ayoub A, Abdelsamea Alazab E, Tharwat E, Gamal El Sayed Mostafa T. Outcomes of perfluorocarbon liquid vs. posterior retinotomy as adjuncts during pars-plana vitrectomy for the surgical repair of rhegmatogenous retinal detachment: a randomized clinical trial. BMC Ophthalmol. 2025 Aug 19;25(1):476. doi: 10.1186/s12886-025-04271-w.
PubMed 40830767
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT06919211
- Acronym / sponsor ID
- Ophth._20/2024Med.Research
- Conditions
- Rhegmatogenous Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 9 Apr 2025 (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.
Purpose To evaluate the outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications.
Methods This is a prospective randomized controlled trial that included 58 eyes with RRD, divided into Group A (PFCL, n = 29) and Group B (PR, n = 29). Preoperative assessments included best-corrected visual acuity (BCVA), IOP, axial length, lens status, macula status, and PVR grade. Outcomes were evaluated at 1 week, 1 month, 2 months, and 3 months postoperatively. Primary outcomes included retinal reattachment rates and the number of operations; secondary outcomes included BCVA, IOP changes, complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perfluorocarbon Liquid Group | Experimental | Procedure: Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment |
| Posterior Retinotomy Group | Experimental | Procedure: Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A clear diagnosis of primary RRD requiring surgery, 18 years or older, The potential to return for follow-up visits for at least 6 months post-surgery.
Key exclusion criteria (1 listed)
- When presented with tractional or exudative retinal detachment, had surgery on the affected eye in the past, presented with severe eye disorders like advanced glaucoma or endophthalmitis.
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 |
|---|---|---|
| Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal DetachmentThis study compares outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications | Procedure or surgery | Perfluorocarbon Liquid Group, Posterior Retinotomy Group |
Primary outcome
Retinal reattachment rates
Time frame: One month, Two months, and Three Months
Number of operations
Time frame: One month, Two months, and Three Monthes
3 secondary outcomes
Best-corrected visual acuity (BCVA)
Time frame: One month, Two months, and Three Monthes
Intraocular pressure (IOP)
Time frame: One month, Two months, and Three Monthes
Complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success
Time frame: One month, Two months, and Three Monthes
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 9 Apr 2025.
- Results publication: PubMed 37007660Vo LV, Ryan EH, Ryan CM, Shah GK, Gupta OP, Capone A Jr, Eliott D, Yonekawa Y, Bhavsar AR, Emerson MV, Jones JM, Emerson GG. Posterior Retinotomy vs Perfluorocarbon Liquid to Aid Drainage of Subretinal Fluid During Primary Rhegmatogenous Retinal Detachment Repair (PRO Study Report No. 10). J Vitreoretin Dis. 2020 Aug 12;4(6):494-498. doi: 10.1177/2474126420941372. eCollection 2020 Nov-Dec.
- Results publication: PubMed 29912572Vidne O, Blum Meirovitch S, Rabina G, Abd Eelkader A, Prat D, Barequet D, Moisseiev J, Moisseiev E. Perfluorocarbon Liquid Vs. Subretinal Fluid Drainage during Vitrectomy for the Primary Repair of Rhegmatogenous Retinal Detachment: A Comparative Study. Curr Eye Res. 2018 Nov;43(11):1389-1394. doi: 10.1080/02713683.2018.1490436. Epub 2018 Jul 9.
- Derived from this study: PubMed 40830767Mohamed Elsayed Saad E, Elbadry Mohammed Mohammed H, Mohamed-Aly Ibrahim M, Hassan Salama Selim O, Mostafa Elsayed Abdelhafeez S, Mohammed Sakr A, Mohamed Abo Elftouh Elsalhy F, Abdelmohsen Ali Ayoub A, Abdelsamea Alazab E, Tharwat E, Gamal El Sayed Mostafa T. Outcomes of perfluorocarbon liquid vs. posterior retinotomy as adjuncts during pars-plana vitrectomy for the surgical repair of rhegmatogenous retinal detachment: a randomized clinical trial. BMC Ophthalmol. 2025 Aug 19;25(1):476. doi: 10.1186/s12886-025-04271-w.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment in people with Rhegmatogenous Retinal Detachment, run by Benha 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 1 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 9 Apr 2025. 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?
Retinal reattachment rates (time frame: One month, Two months, and Three Months). The study lists 2 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 NCT06919211, which also lists 3 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 9 Apr 2025.