Head Positioning After Retina Detachment Repair

Retina; Detachment, Rhegmatogenous Clinical Trial

Official title:

Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03714503
• Other study ID #: STUDY00142574
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: October 2025

Study information

• Verified date: March 2023
• Source: University of Kansas Medical Center
• Contact: Ashley Small, MPH
• Phone: 913-588-0105
• Email: asmall2[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigator will conduct a single arm phase II study using a Simon's two-stage design

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retina; Detachment, Rhegmatogenous
• Retinal Detachment

Intervention

Device:
• Retina re-attachment repair using C3F8 gas tamponade
Assigning a one day post-operative head positioning

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Prairie Village	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retina attachment on clinical exam using the indirect ophthalmoscope	Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees	3 months
Secondary	Retina attachment on clinical exam using the indirect ophthalmoscope	Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees	1 year