Retinal DetachmentNCT05561569
Air Versus Gas Tamponade in Primary Retinal Detachment
A study testing Pars plana vitrectomy in people with Retinal Detachment and Proliferative Vitreoretinopathy, run by Benha University at 1 site in Egypt.
Trial summary
Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Retinal Detachment, Proliferative Vitreoretinopathy
- What is being tested?
- Pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Sep 2022to 1 Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.
Who cannot join
- cases with combined tractional retinal detachment.
- cases with recurrent retinal detachment.
- cases that are eligible for scleral buckling that have no traction on retinal break.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy
Banhā, QA, 13511
Ahmed Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
Mahrous H Shaheen, MD, 0846300587, mha13@fayoum.edu.eg
About this study
Official title: Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment
Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.
Read the detailed description
There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade.
In this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.
- Being tested
- Pars plana vitrectomy
- Keywords
- Vitrectomy, Retinal detachment
- Medical subject headings
- Retinal Detachment, Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomyProcedure or surgery
23 gauge pars plana vitrectomy for managing primary retinal detachment.
| Study group | Role | What they receive |
|---|---|---|
| Air tamponade group | Active comparator | Cases with primary upper retinal detachment that will be treated with air tamponade. Receives: Procedure: Pars plana vitrectomy |
| Non expansile gas tamponade group | Active comparator | Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade. Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in visual acuity
Visual acuity changes measured by snellen chart and converted to LogMar units.
Measured: Change from baseline visual acuity at 6th month.
Secondary outcomes (1)
Changes in metamorphopsia
Changes in metamorphopsia after surgery assessed by M-chart that is specially designed to subjectively assess metamorphopsia, each 1 millimeter deviation from reference line is considered significant deviation.
Measured: Change from baseline metamorphopsia at 6th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start26 Sep 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 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.
- 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
- 40 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 Abdelshafy, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561569
- Sponsor's protocol ID
- Rc.11-2022
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 30 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 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment
- ClinicalTrials.gov ID
- NCT05561569
- Acronym / sponsor ID
- Rc.11-2022
- Keywords
- Vitrectomy, Retinal detachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 30 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.
Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.
Detailed description
There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade.
In this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air tamponade group | Active comparator | Procedure: Pars plana vitrectomyCases with primary upper retinal detachment that will be treated with air tamponade. |
| Non expansile gas tamponade group | Active comparator | Procedure: Pars plana vitrectomyCases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.
Key exclusion criteria (3 listed)
- cases with combined tractional retinal detachment.
- cases with recurrent retinal detachment.
- cases that are eligible for scleral buckling that have no traction on retinal break.
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 vitrectomy23 gauge pars plana vitrectomy for managing primary retinal detachment. | Procedure or surgery | Air tamponade group, Non expansile gas tamponade group |
Primary outcome
Improvement in visual acuity
Time frame: Change from baseline visual acuity at 6th month.
Visual acuity changes measured by snellen chart and converted to LogMar units.
1 secondary outcome
Changes in metamorphopsia
Time frame: Change from baseline metamorphopsia at 6th month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- 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.
Ahmed A Abdelshafy, 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 Pars plana vitrectomy in people with Retinal Detachment and Proliferative Vitreoretinopathy, 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 3 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 30 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 Abdelshafy, 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?
Improvement in visual acuity (time frame: Change from baseline visual acuity at 6th month.). 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 30 Sep 2022.