Retina; Detachment, RhegmatogenousNCT03714503
Head Positioning After Retina Detachment Repair
A study testing Retina re-attachment repair using C3F8 gas tamponade in people with Retina; Detachment, Rhegmatogenous, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study aims to determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV) using perfluoropropane (C3F8) gas as a tamponade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retina; Detachment, Rhegmatogenous
- What is being tested?
- Retina re-attachment repair using C3F8 gas tamponade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent
- Subjects must be diagnosed with primary rhegmatogenous retinal detachment with inferior breaks
- Subjects must be 18 years and older.
- Women of child-bearing potential must agree to take rapid urine pregnancy test before surgical procedure and have negative result.
Who cannot join
- pediatric population
- pregnant women
- a previous retinal detachment repair in the study eye
- history of scleral buckling in the study eye
- trauma as a cause of the retinal detachment
- asymptomatic longstanding retinal detachments
Show all 10Show fewer
- non-compliance with post-operative treatment
- phakic retinal detachment
- exudative retinal detachment
- retinoschisis related retinal detachment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Prairie Village, Kansas, 66208
Ariana Madrigal, 913-588-0105, amadrigal2@kumc.edu
Abby Strickland, astrickland2@kumc.edu
About this study
Official title: Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas
This study aims to determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV) using perfluoropropane (C3F8) gas as a tamponade. The investigator will conduct a single arm phase II study using a Simon's two-stage design
Read the detailed description
- Study Objectives: To determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after PPV using C3F8 gas as a tamponade.
- Primary outcome: retina anatomical success at 3 months post-operatively
- Secondary outcome: retina anatomical success at 1 year post-operatively
- Study Type and Design: Single arm phase II study to assess its effectiveness and warrant interest in further development. A Simon's two-stage design will be used to test the following hypotheses: null hypothesis (HO): P<=0.6 versus alternative hypothesis (HI): p >= 0.85.
- Sample size, statistical methods, and power calculation
- The sample size calculations are based on a Simon's two-stage minimax design. The Investigators plan to recruit 20 patients (20 eyes) with one day post-operative head positioning. This trial will run as a single-arm study in two stages. In the first stage, the Investigators will define a futility rate of 60%. Thus, 11 patients will be enrolled in this stage and if seven or less than seven patients are not declared a "success", the Investigators will terminate this trial after the first stage. If eight or more successes are found in the first stage, the Investigators will continue to the second stage where the Investigators will enroll an additional 9 patients taking the total sample size to 20 patients. The treatment will be considered as promising for future research if the results find that 16 or more than 16 of the 20 patients are declared a 'success' (based on the literature review and a retrospective study, a success rate of 85% is chosen). This minimax design has an expected sample size of 14 patients and a probability of early termination (PET) of 70%. An analogous calculation for the Optimal Simon's design gives a total sample size of 28 but with the same expected sample size of 14, and so the Investigators have decided to adopt the minimax design.
- Conditions
- Retina; Detachment, Rhegmatogenous
- Being tested
- Retina re-attachment repair using C3F8 gas tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retina re-attachment repair using C3F8 gas tamponadeDevice
Also called pars plana vitrectomy
Assigning a one day post-operative head positioning
| Study group | Role | What they receive |
|---|---|---|
| One day post-operative head positioning | Other | patients will be assigned to remain a one-day post operative head positioning following retina re-attachment surgery Receives: Device: Retina re-attachment repair using C3F8 gas tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retina attachment on clinical exam using the indirect ophthalmoscope
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
Measured: 3 months
Secondary outcomes (1)
Retina attachment on clinical exam using the indirect ophthalmoscope
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start8 Apr 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retina; Detachment, RhegmatogenousStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simon's two stage
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radwan Ajlan, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714503
- Sponsor's protocol ID
- STUDY00142574
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas
- ClinicalTrials.gov ID
- NCT03714503
- Acronym / sponsor ID
- STUDY00142574
- Conditions
- Retina; Detachment, Rhegmatogenous
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Oct 2018 (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.
This study aims to determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV) using perfluoropropane (C3F8) gas as a tamponade. The investigator will conduct a single arm phase II study using a Simon's two-stage design
Detailed description
- Study Objectives: To determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after PPV using C3F8 gas as a tamponade.
- Primary outcome: retina anatomical success at 3 months post-operatively
- Secondary outcome: retina anatomical success at 1 year post-operatively
- Study Type and Design: Single arm phase II study to assess its effectiveness and warrant interest in further development. A Simon's two-stage design will be used to test the following hypotheses: null hypothesis (HO): P<=0.6 versus alternative hypothesis (HI): p >= 0.85.
- Sample size, statistical methods, and power calculation
- The sample size calculations are based on a Simon's two-stage minimax design. The Investigators plan to recruit 20 patients (20 eyes) with one day post-operative head positioning. This trial will run as a single-arm study in two stages. In the first stage, the Investigators will define a futility rate of 60%. Thus, 11 patients will be enrolled in this stage and if seven or less than seven patients are not declared a "success", the Investigators will terminate this trial after the first stage. If eight or more successes are found in the first stage, the Investigators will continue to the second stage where the Investigators will enroll an additional 9 patients taking the total sample size to 20 patients. The treatment will be considered as promising for future research if the results find that 16 or more than 16 of the 20 patients are declared a 'success' (based on the literature review and a retrospective study, a success rate of 85% is chosen). This minimax design has an expected sample size of 14 patients and a probability of early termination (PET) of 70%. An analogous calculation for the Optimal Simon's design gives a total sample size of 28 but with the same expected sample size of 14, and so the Investigators have decided to adopt the minimax design.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's two stage
| Arm | Type | Receives |
|---|---|---|
| One day post-operative head positioning | Other | Device: Retina re-attachment repair using C3F8 gas tamponadepatients will be assigned to remain a one-day post operative head positioning following retina re-attachment surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to understand and the willingness to sign a written informed consent
- Subjects must be diagnosed with primary rhegmatogenous retinal detachment with inferior breaks
- Subjects must be 18 years and older.
- Women of child-bearing potential must agree to take rapid urine pregnancy test before surgical procedure and have negative result.
Key exclusion criteria (10 listed)
- pediatric population
- pregnant women
- a previous retinal detachment repair in the study eye
- history of scleral buckling in the study eye
- trauma as a cause of the retinal detachment
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 |
|---|---|---|
| Retina re-attachment repair using C3F8 gas tamponadeAlso: pars plana vitrectomyAssigning a one day post-operative head positioning | Device | One day post-operative head positioning |
Primary outcome
Retina attachment on clinical exam using the indirect ophthalmoscope
Time frame: 3 months
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
1 secondary outcome
Retina attachment on clinical exam using the indirect ophthalmoscope
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- 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.
Radwan Ajlan, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retina re-attachment repair using C3F8 gas tamponade in people with Retina; Detachment, Rhegmatogenous, run by University of Kansas Medical Center at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariana Madrigal (9135880105, amadrigal2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retina attachment on clinical exam using the indirect ophthalmoscope (time frame: 3 months). 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 5 May 2026.