Retinal DetachmentNCT04139811
Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD
A study testing Pars Plana Vitrectomy in people with Retinal Detachment, run by Minia University at 1 site in Egypt.
Trial summary
Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion. Read more about this study
- Who is it for?
- Ages 20 to 73 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Pars Plana Vitrectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2017to 15 Aug 2019
- 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 20 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).
Who cannot join
- Complicated cases with advanced proliferative vitreoretinopathy (PVR).
- Patients with retinal vascular disorders and other macular disorders.
- Combined tractional and rhegmatogenous detachment.
- Previous retinal reattachment surgery or Intravitreal injections.
- Glaucomatous patients.
- Patients with corneal opacity which impairs good visualization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment
Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.
The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.
In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.
Read the detailed description
interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.
- Conditions
- Retinal Detachment
- Being tested
- Pars Plana Vitrectomy
- Keywords
- Internal limiting membrane, multifocal electoretinogram (ERG), OCT-Angiography
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars Plana VitrectomyOther
vitrectomy with and without ILM peeling
| Study group | Role | What they receive |
|---|---|---|
| non-ILM peeling group | Other | vitrectomy without ILM peeling is done to all cases Receives: Other: Pars Plana Vitrectomy |
| ILM peeling group | Other | vitrectomy with ILM peeling is done to all cases Receives: Other: Pars Plana Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical outcome
Rate of retinal reattachment using indirect ophthalmoscopy
Measured: 6 months follow up
epiretinal membrane
incidence rate of epiretinal membrane formation after surgery in % percent
Measured: 6 months follow up
Secondary outcomes (3)
functional outcome
visual functions using log Mar Best Corrected Visual Acuity (BCVA)
Measured: 6 months follow up
superficial capillary density
measurement of percent (%) of superficial and deep capillary density using Optical Coherance Tomography Angiography
Measured: 6 months follow up
multi-focal Electroretinogram
measurement of P1 amplitude
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start15 Mar 2017
- Primary completion15 Jul 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Minia 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mohamed Moharram, Minia University
- Investigators
- Mohamed F Othman, MD, Principal investigator, sub-investigatorAhmed Shawkat, MD, Principal investigator, sub-investigatorkhalid Murad, Principal investigator, sub-investigatorMohamed Abdullah, Principal investigator, sub-investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139811
- Sponsor's protocol ID
- 66-7/2018
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdullah ME, Moharram HEM, Abdelhalim AS, Mourad KM, Abdelkader MF. Evaluation of primary internal limiting membrane peeling in cases with rhegmatogenous retinal detachment. Int J Retina Vitreous. 2020 May 7;6:8. doi: 10.1186/s40942-020-00213-4. eCollection 2020.
PubMed 32411388
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT04139811
- Acronym / sponsor ID
- 66-7/2018
- Conditions
- Retinal Detachment
- Keywords
- Internal limiting membrane, multifocal electoretinogram (ERG), OCT-Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 25 Oct 2019 (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.
Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.
The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.
In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.
Detailed description
interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-ILM peeling group | Other | Other: Pars Plana Vitrectomyvitrectomy without ILM peeling is done to all cases |
| ILM peeling group | Other | Other: Pars Plana Vitrectomyvitrectomy with ILM peeling is done to all cases |
Who may qualify
- Ages
- 20 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).
Key exclusion criteria (6 listed)
- Complicated cases with advanced proliferative vitreoretinopathy (PVR).
- Patients with retinal vascular disorders and other macular disorders.
- Combined tractional and rhegmatogenous detachment.
- Previous retinal reattachment surgery or Intravitreal injections.
- Glaucomatous patients.
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 Vitrectomyvitrectomy with and without ILM peeling | Other | ILM peeling group, non-ILM peeling group |
Primary outcome
anatomical outcome
Time frame: 6 months follow up
Rate of retinal reattachment using indirect ophthalmoscopy
epiretinal membrane
Time frame: 6 months follow up
incidence rate of epiretinal membrane formation after surgery in % percent
3 secondary outcomes
functional outcome
Time frame: 6 months follow up
superficial capillary density
Time frame: 6 months follow up
multi-focal Electroretinogram
Time frame: 6 months follow up
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 25 Oct 2019.
- Derived from this study: PubMed 32411388Abdullah ME, Moharram HEM, Abdelhalim AS, Mourad KM, Abdelkader MF. Evaluation of primary internal limiting membrane peeling in cases with rhegmatogenous retinal detachment. Int J Retina Vitreous. 2020 May 7;6:8. doi: 10.1186/s40942-020-00213-4. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Mohamed F Othman, MD principal investigator
sub-investigator
Ahmed Shawkat, MD principal investigator
sub-investigator
khalid Murad principal investigator
sub-investigator
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 in people with Retinal Detachment, run by Minia 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 6 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 25 Oct 2019. 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?
anatomical outcome (time frame: 6 months follow up). 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 NCT04139811, which also lists 1 linked publication.
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 25 Oct 2019; AzTrials last refreshed its copy on 4 Nov 2026.