Retinal DetachmentNCT03218371
Scleral Self-indentation Chandelier-assisted Peripheral Vitrectomy Under Air Rhegmatogenous Retinal Detachment.
An observational study of Retinal Detachment, run by Dar El Oyoun Hospital at 1 site in Egypt.
Trial summary
The investigators compared the incidence of trimming-induced retinal breaks, retinal redetachment rate, and final LogMAR BCVA; between scleral self-indentation and non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with primary retinal detachment. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- chandelier-assisted peripheral vitrectomy under air
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2013to Apr 2017
- Phase
- Observational
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a retrospective cohort study that was done on eyes (participants) with rhegmatogenous retinal detachment (RRD) for whom chandelier-assisted peripheral vitrectomy under air (CPVA) had been performed; whether using scleral self-indentation (Exposure), or without scleral self-indentation (control)
Who may be able to join
- RRD with postoperative follow up > 3 months, without PVR, or with PVR A-B
Who cannot join
- RRD with less than 3 months of postoperative follow-up,
- RRD with proliferative vitreoretinopathy grade C (PVR C),
- RRD with uveitis,
- RRD with choroidal detachment,
- Giant retinal tears,
- Retinal dialysis,
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- Myopic macular hole RRD,
- Traumatic RD,
- Children < 16 years old,
- The later vitrectomy (if vitrectomy had been performed for RRD in both eyes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scleral Self-indentation During Chandelier-assisted Peripheral Vitrectomy Under Air for Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study.
The investigators compared the incidence of trimming-induced retinal breaks, retinal redetachment rate, and final LogMAR BCVA; between scleral self-indentation and non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with primary retinal detachment. Self-indentation enables complete trimming of the vitreous base without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with less need for chandelier shift than with non-indentation approach.
Read the detailed description
Retrospective cohort study. One hundred and thirty eyes of 130 participants with primary rhegmatogenous retinal detachment were identified. All the participants had undergone a chandelier-assisted peripheral vitrectomy under air. Scleral self-indentation had been used in 68 eyes (study group) (Indentation group), while non-indentation had been used in 62 eyes (comparison group) (Non-indentation group). Outcome variables included: Trimming-induced retinal breaks (TIRB), retinal redetachment rate, final LogMAR BCVA, and intraoperative complications.
- Conditions
- Retinal Detachment
- Being tested
- chandelier-assisted peripheral vitrectomy under air
- Keywords
- scleral indentation, chandelier light, air vitrectomy, rhegmatogenous retinal detachment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chandelier-assisted peripheral vitrectomy under airProcedure or surgery
chandelier-assisted peripheral vitrectomy under air for management of peripheral vitreous during RD vitrectomy; whether using indentation or non-indentation
| Study group | Role | What they receive |
|---|---|---|
| study group (Indentation) | Eyes (participants) for whom chandelier-assisted peripheral vitrectomy under air had been performed with scleral indentation. (Exposure) Receives: Procedure: chandelier-assisted peripheral vitrectomy under air | |
| control group (Non-indentation) | eyes (participants) for whom chandelier-assisted peripheral vitrectomy under air had been performed without scleral indentation. Receives: Procedure: chandelier-assisted peripheral vitrectomy under air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trimming-induced retinal breaks (TIRB) (yes/ No)
number of eyes with iatrogenic retinal breaks along vitreous base during vitreous base trimming
Measured: intraoperative
Secondary outcomes (6)
number of Trimming-induced retinal breaks (TIRB)
number of iatrogenic retinal breaks along vitreous base during vitreous base trimming
Measured: intraoperative
retinal redetachment rate (yes/no)
number of eyes in which recurrent retinal detachment occurred
Measured: within 3 months
final LogMAR BCVA
best spectacle corrected visual acuity measured by decimal charts then converted to LogMAR
Measured: final follow-up visit ( at least 3 months)
snellen BCVA > 20/100 (yes/ no)
number of eyes with best corrected visual acuity better than snellen's 20/100 measured by snellen's chart
Measured: 3 months
Chandelier shift (yes/no)
the need to shift position of chandelier light
Measured: intraoperative
Local anaesthesia augmentation (yes/no)
the need for augmenting local anesthesia for the participant to tolerate indentation
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startOct 2013
- Primary completionJan 2016
- Study completionApr 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar El Oyoun Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Ahmed Ewais, Dar El Oyoun Hospital
- Investigators
- Wael A Ewais, MD, Principal investigator, consultant vitreoretinal surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218371
- Sponsor's protocol ID
- DEO00001258
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleral Self-indentation During Chandelier-assisted Peripheral Vitrectomy Under Air for Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03218371
- Acronym / sponsor ID
- DEO00001258
- Conditions
- Retinal Detachment
- Keywords
- scleral indentation, chandelier light, air vitrectomy, rhegmatogenous retinal detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Dar El Oyoun HospitalUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Jul 2017 (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.
The investigators compared the incidence of trimming-induced retinal breaks, retinal redetachment rate, and final LogMAR BCVA; between scleral self-indentation and non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with primary retinal detachment. Self-indentation enables complete trimming of the vitreous base without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with less need for chandelier shift than with non-indentation approach.
Detailed description
Retrospective cohort study. One hundred and thirty eyes of 130 participants with primary rhegmatogenous retinal detachment were identified. All the participants had undergone a chandelier-assisted peripheral vitrectomy under air. Scleral self-indentation had been used in 68 eyes (study group) (Indentation group), while non-indentation had been used in 62 eyes (comparison group) (Non-indentation group). Outcome variables included: Trimming-induced retinal breaks (TIRB), retinal redetachment rate, final LogMAR BCVA, and intraoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (Indentation) | – | Procedure: chandelier-assisted peripheral vitrectomy under airEyes (participants) for whom chandelier-assisted peripheral vitrectomy under air had been performed with scleral indentation. (Exposure) |
| control group (Non-indentation) | – | Procedure: chandelier-assisted peripheral vitrectomy under aireyes (participants) for whom chandelier-assisted peripheral vitrectomy under air had been performed without scleral indentation. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective cohort study that was done on eyes (participants) with rhegmatogenous retinal detachment (RRD) for whom chandelier-assisted peripheral vitrectomy under air (CPVA) had been performed; whether using scleral self-indentation (Exposure), or without scleral self-indentation (control)
Key inclusion criteria (1 listed)
- RRD with postoperative follow up > 3 months, without PVR, or with PVR A-B
Key exclusion criteria (10 listed)
- RRD with less than 3 months of postoperative follow-up,
- RRD with proliferative vitreoretinopathy grade C (PVR C),
- RRD with uveitis,
- RRD with choroidal detachment,
- Giant retinal tears,
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 |
|---|---|---|
| chandelier-assisted peripheral vitrectomy under airchandelier-assisted peripheral vitrectomy under air for management of peripheral vitreous during RD vitrectomy; whether using indentation or non-indentation | Procedure or surgery | control group (Non-indentation), study group (Indentation) |
Primary outcome
Trimming-induced retinal breaks (TIRB) (yes/ No)
Time frame: intraoperative
number of eyes with iatrogenic retinal breaks along vitreous base during vitreous base trimming
6 secondary outcomes
number of Trimming-induced retinal breaks (TIRB)
Time frame: intraoperative
retinal redetachment rate (yes/no)
Time frame: within 3 months
final LogMAR BCVA
Time frame: final follow-up visit ( at least 3 months)
snellen BCVA > 20/100 (yes/ no)
Time frame: 3 months
Chandelier shift (yes/no)
Time frame: intraoperative
Local anaesthesia augmentation (yes/no)
Time frame: intraoperative
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 14 Jul 2017.
- 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.
Wael A Ewais, MD principal investigator
consultant vitreoretinal surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment, run by Dar El Oyoun Hospital 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 10 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 14 Jul 2017. 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?
Trimming-induced retinal breaks (TIRB) (yes/ No) (time frame: intraoperative). 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 14 Jul 2017.