Retinal DetachmentNCT05583253
Visual Outcome of Vitrectomy After Refractive Surgery
A study testing Vitrectomy in people with Retinal Detachment and Refractive Errors, run by Benha University at 1 site in Egypt.
Trial summary
Results of retinal detachment surgery may be affected in cases with history of previous intraocular surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Retinal Detachment, Refractive Errors
- What is being tested?
- Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2022to 30 Aug 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- cases diagnosed with primary retinal detachment and prepared for pars-plana vitrectomy.
- cases with previous history for refractive surgery were enrolled in refractive surgery group.
Who cannot join
- cases with corneal diseases or trauma that may affect the final visual outcome.
- cases with other retinal diseases that may affect the final visual outcome as age related macular degenerations and diabetic eye disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benha University
Banhā, QA, 13511
Ahmed Abdelshafy, 01222328766, ahmad4lg@gmail.com
ahmad4lg@gmail.com
About this study
Official title: Visual Outcome of Small Gauge Pars-plana Vitrectomy for Retinal Detachment With Previous Refractive Surgery
Results of retinal detachment surgery may be affected in cases with history of previous intraocular surgery.
Read the detailed description
Pars-plana vitrectomy for management of retinal detachment has favorable visual outcome with early intervention and development of small gauge instruments, cases with previous refractive surgery may be affected by other factors that may change the final visual outcome.
In this study, we aim to analyze the effect of refractive surgeries on the final visual outcome after vitrectomy for the management of retinal detachment.
- Conditions
- Retinal Detachment, Refractive Errors
- Being tested
- Vitrectomy
- Medical subject headings
- Retinal Detachment, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
Also called Pars-plana vitrectomy
Small gauge pars-plana vitrectomy for management of retinal detachment.
| Study group | Role | What they receive |
|---|---|---|
| Vitrectomy group with previous refractive surgery | Active comparator | Cases with primary retinal detachment that are prepared for pars-plana vitrectomy with previous history of refractive surgery. Receives: Procedure: Vitrectomy |
| Vitrectomy group with no previous intraocular surgery | Active comparator | Subjects with primary retinal detachment that are prepared for pars-plana vitrectomy with no previous history of intraocular surgery. Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Changes in visual acuity from baseline and at the 6th month of follow-up measured by snellen chart and converted to logMAR units for statistical analysis.
Measured: Baseline and 6 months after surgery.
Secondary outcomes (1)
Corneal endothelial cells count
Changes in corneal endothelial cells counts measured by specular microscopy in cells/millimeters2 units.
Measured: Baseline and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start13 Oct 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Aug 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Marwa A Abdelshafy, MD, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583253
- Sponsor's protocol ID
- Rc 12-2022
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 17 Oct 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 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcome of Small Gauge Pars-plana Vitrectomy for Retinal Detachment With Previous Refractive Surgery
- ClinicalTrials.gov ID
- NCT05583253
- Acronym / sponsor ID
- Rc 12-2022
- Conditions
- Retinal Detachment, Refractive Errors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 17 Oct 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.
Results of retinal detachment surgery may be affected in cases with history of previous intraocular surgery.
Detailed description
Pars-plana vitrectomy for management of retinal detachment has favorable visual outcome with early intervention and development of small gauge instruments, cases with previous refractive surgery may be affected by other factors that may change the final visual outcome.
In this study, we aim to analyze the effect of refractive surgeries on the final visual outcome after vitrectomy for the management of retinal detachment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitrectomy group with previous refractive surgery | Active comparator | Procedure: VitrectomyCases with primary retinal detachment that are prepared for pars-plana vitrectomy with previous history of refractive surgery. |
| Vitrectomy group with no previous intraocular surgery | Active comparator | Procedure: VitrectomySubjects with primary retinal detachment that are prepared for pars-plana vitrectomy with no previous history of intraocular surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- cases diagnosed with primary retinal detachment and prepared for pars-plana vitrectomy.
- cases with previous history for refractive surgery were enrolled in refractive surgery group.
Key exclusion criteria (2 listed)
- cases with corneal diseases or trauma that may affect the final visual outcome.
- cases with other retinal diseases that may affect the final visual outcome as age related macular degenerations and diabetic eye disease.
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 |
|---|---|---|
| VitrectomyAlso: Pars-plana vitrectomySmall gauge pars-plana vitrectomy for management of retinal detachment. | Procedure or surgery | Vitrectomy group with no previous intraocular surgery, Vitrectomy group with previous refractive surgery |
Primary outcome
Visual acuity
Time frame: Baseline and 6 months after surgery.
Changes in visual acuity from baseline and at the 6th month of follow-up measured by snellen chart and converted to logMAR units for statistical analysis.
1 secondary outcome
Corneal endothelial cells count
Time frame: Baseline and 6 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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Intraoperative OCT Guidance of Intraocular Surgery II
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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.
Marwa A Abdelshafy, MD study director
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 Vitrectomy in people with Retinal Detachment and Refractive Errors, 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 17 Oct 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?
Visual acuity (time frame: Baseline and 6 months after surgery.). 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 17 Oct 2022.