Head Positioning After Retina Detachment Repair
Primary Purpose
Retina; Detachment, Rhegmatogenous
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retina re-attachment repair using C3F8 gas tamponade
Sponsored by
About this trial
This is an interventional health services research trial for Retina; Detachment, Rhegmatogenous
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- non-compliance with post-operative treatment
- phakic retinal detachment
- exudative retinal detachment
- retinoschisis related retinal detachment
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
One day post-operative head positioning
Arm Description
patients will be assigned to remain a one-day post operative head positioning following retina re-attachment surgery
Outcomes
Primary Outcome Measures
Retina attachment on clinical exam using the indirect ophthalmoscope
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
Secondary Outcome Measures
Retina attachment on clinical exam using the indirect ophthalmoscope
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
Full Information
NCT ID
NCT03714503
First Posted
October 4, 2018
Last Updated
March 31, 2023
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03714503
Brief Title
Head Positioning After Retina Detachment Repair
Official Title
Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. The investigator will conduct a single arm phase II study using a Simon's two-stage design
Detailed Description
A. 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
B. 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.
C. Sample size, statistical methods, and power calculation
1. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retina; Detachment, Rhegmatogenous
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Simon's two stage
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One day post-operative head positioning
Arm Type
Other
Arm Description
patients will be assigned to remain a one-day post operative head positioning following retina re-attachment surgery
Intervention Type
Device
Intervention Name(s)
Retina re-attachment repair using C3F8 gas tamponade
Other Intervention Name(s)
pars plana vitrectomy
Intervention Description
Assigning a one day post-operative head positioning
Primary Outcome Measure Information:
Title
Retina attachment on clinical exam using the indirect ophthalmoscope
Description
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Retina attachment on clinical exam using the indirect ophthalmoscope
Description
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
non-compliance with post-operative treatment
phakic retinal detachment
exudative retinal detachment
retinoschisis related retinal detachment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Small, MPH
Phone
913-588-0105
Email
asmall2@kumc.edu
Facility Information:
Facility Name
University of Kansas Medical Center
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Small
Phone
913-588-0105
Email
asmall2@kumc.edu
First Name & Middle Initial & Last Name & Degree
Radwan S Ajlan, MBBCh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Head Positioning After Retina Detachment Repair
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