Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT03714503

Conditions

Retina; Detachment, Rhegmatogenous

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Retina re-attachment repair using C3F8 gas tamponade

Study Details

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

Conditions

Retina; Detachment, Rhegmatogenous

Study ID

NCT03714503

Start date

Apr 8, 2019

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: One day post-operative head positioning

patients will be assigned to remain a one-day post operative head positioning following retina re-attachment surgery

Interventions

Retina re-attachment repair using C3F8 gas tamponade

Assigning a one day post-operative head positioning

Primary outcome measure

  • Retina attachment on clinical exam using the indirect ophthalmoscope [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Ariana Madrigal

9135880105amadrigal2@kumc.edu

Abby Strickland

913-588-6600astrickland2@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Prairie Village, Kansas, United States, 66208

Contacts

Ariana Madrigal

913-588-0105amadrigal2@kumc.edu

Abby Strickland

astrickland2@kumc.edu

Principal Investigator:

Radwan S Ajlan, MBBCh

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.