Retinal DetachmentNCT05543018
Effect of Intraocular Tamponade on Visual Perception
A study testing Electroretinogram and Vitrectomy operation in people with Retinal Detachment and Optic Neuropathy, run by Benha University at 1 site in Egypt.
Trial summary
Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Retinal Detachment, Optic Neuropathy, Glaucoma
- What is being tested?
- Electroretinogram and Vitrectomy operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2022to 28 Oct 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary retinal detachment patients.
- patients eligible for 23 gauge pars-plana vitrectomy operation.
Who cannot join
- patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function.
- patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy Tabl
Banhā, Benha, 13511
Ahmed A Tabl, 01222328766, ahmad4lg@gmail.com
Marwa Abdelshafy, MD
About this study
Official title: Effect of Intraocular Tamponade on Visual Function in the Human Eyes
Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.
Read the detailed description
Various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. The effects of these intraocular tamponade may affects the final visual outcome of the surgery.
- Conditions
- Retinal Detachment, Optic Neuropathy, Glaucoma
- Being tested
- Electroretinogram, Vitrectomy operation
- Keywords
- Vitrectomy, Retinal detachment, Intraocular Tamponade, Silicon oil, Air tamponade
- Medical subject headings
- Retinal Detachment, Optic Nerve Diseases, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroretinogramDiagnostic test
Retinal function assessment using electroretinogram
Vitrectomy operationProcedure or surgery
Vitrectomy operation to treat retinal detachment
| Study group | Role | What they receive |
|---|---|---|
| Silicon oil group | Active comparator | Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade. Receives: Diagnostic Test: Electroretinogram; Procedure: Vitrectomy operation |
| Air tamponade | Active comparator | Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade. Receives: Diagnostic Test: Electroretinogram; Procedure: Vitrectomy operation |
| Non-expansile gas | Active comparator | Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride). Receives: Diagnostic Test: Electroretinogram; Procedure: Vitrectomy operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Changes in visual acuity measured in LogMAR units.
Measured: Baseline and monthly after surgery till 6 months of follow up.
Retinal function amplitude
Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.
Measured: Baseline and monthly after surgery till 6 months of follow up.
Retinal function implicit time.
Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.
Measured: Baseline and monthly after surgery till 6 months of follow up.
Secondary outcomes (1)
Intraocular pressure
Changes in intraocular pressure measured by goldman applanation tonometry in millimeter mercury.
Measured: Baseline and monthly after surgery till 6 months of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start12 Sep 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion28 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Tabl, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543018
- Sponsor's protocol ID
- RC-10-22
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraocular Tamponade on Visual Function in the Human Eyes
- ClinicalTrials.gov ID
- NCT05543018
- Acronym / sponsor ID
- RC-10-22
- Conditions
- Retinal Detachment, Optic Neuropathy, Glaucoma
- Keywords
- Vitrectomy, Retinal detachment, Intraocular Tamponade, Silicon oil, Air tamponade
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 28 Oct 2023 (estimated)
- First posted
- 16 Sep 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.
Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.
Detailed description
Various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. The effects of these intraocular tamponade may affects the final visual outcome of the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silicon oil group | Active comparator | Diagnostic Test: Electroretinogram, Procedure: Vitrectomy operationPatients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade. |
| Air tamponade | Active comparator | Diagnostic Test: Electroretinogram, Procedure: Vitrectomy operationPatients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade. |
| Non-expansile gas | Active comparator | Diagnostic Test: Electroretinogram, Procedure: Vitrectomy operationPatients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary retinal detachment patients.
- patients eligible for 23 gauge pars-plana vitrectomy operation.
Key exclusion criteria (2 listed)
- patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function.
- patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.
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 |
|---|---|---|
| ElectroretinogramRetinal function assessment using electroretinogram | Diagnostic test | Air tamponade, Non-expansile gas, Silicon oil group |
| Vitrectomy operationVitrectomy operation to treat retinal detachment | Procedure or surgery | Air tamponade, Non-expansile gas, Silicon oil group |
Primary outcome
Visual acuity
Time frame: Baseline and monthly after surgery till 6 months of follow up.
Changes in visual acuity measured in LogMAR units.
Retinal function amplitude
Time frame: Baseline and monthly after surgery till 6 months of follow up.
Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.
Retinal function implicit time.
Time frame: Baseline and monthly after surgery till 6 months of follow up.
Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.
1 secondary outcome
Intraocular pressure
Time frame: Baseline and monthly after surgery till 6 months of follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
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.
Ahmed A Tabl, MD principal investigator
Benha 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 Electroretinogram and Vitrectomy operation in people with Retinal Detachment and Optic Neuropathy, 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 2 inclusion and 2 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 16 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Tabl, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Baseline and monthly after surgery till 6 months of follow up.). 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?
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 16 Sep 2022.