- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07794163
Anatomical and Functional Outcomes of Pneumatic Retinopexy for Retinal Detachment: A 2-Year Case Series
Anatomical and Functional Outcomes of Pneumatic Retinopexy for Rhegmatogenous Retinal Detachment Using PIVOT Criteria: A 2-Year Case Series From a Referral Center in Southwestern Colombia
연구 개요
상세 설명
Rhegmatogenous retinal detachment (RRD) is a critical ophthalmic emergency caused by full-thickness retinal breaks that permit subretinal fluid accumulation, risking irreversible photoreceptor damage. Pneumatic retinopexy (PnR) combines intravitreal expansile gas injection with laser or cryotherapy retinopexy as a minimally invasive outpatient procedure. Although the landmark PIVOT trial demonstrated the non-inferiority and functional advantages of PnR compared to vitrectomy in selected cases, long-term 2-year prospective evidence on anatomical and functional outcomes in Latin American settings remains limited.
This prospective observational study evaluated 33 phakic adult patients presenting with superior RRD who strictly met adapted PIVOT eligibility criteria at Clínica Oftalmológica Paredes in Pasto, Colombia. Preoperative assessment included a comprehensive evaluation by a retina specialist, best-corrected visual acuity (BCVA), macular OCT (AngioVue/RTVue XR), and wide-field retinal photography (Eidon FA). Before gas injection, 577-nm yellow argon laser photocoagulation was applied to any retinal breaks without associated detachment.
The standardized surgical intervention was performed under topical anesthesia and operating room aseptic conditions, beginning with an anterior chamber paracentesis extracting 0.3 cc of aqueous humor, followed by an inferotemporal injection of 0.7 cc of 100% C3F8 gas 4 mm from the limbus and compressive hemostasis. Following the injection, patients maintained a strict face-down position for one hour and, after verifying foveal reattachment and intraocular pressure, initiated the steam-roll positioning maneuver to guide the gas bubble over the break.
Within 24 to 48 hours post-injection, once retinal reattachment was achieved, complete 577-nm yellow laser photocoagulation was performed around the breaks along with a 360° peripheral laser barrier, while non-responding cases were scheduled for secondary vitrectomy within one week. Long-term follow-up of successful cases was conducted on Day 1, at 3 weeks, 6 weeks, 3 months, and up to 24 months to document primary anatomical success, tear tamponade efficacy, BCVA evolution, IS/OS junction integrity on OCT, intraocular pressure dynamics, and complications such as macular edema or epiretinal membrane formation.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Departamento de Nariño
-
Pasto, Departamento de Nariño, 콜롬비아, 520002
- Clínica Oftalmológica Paredes
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 18 years or older.
- Phakic status in the study eye.
- Diagnosis of primary rhegmatogenous retinal detachment (RRD).
- Single retinal break or a group of breaks extending within 1 clock hour of the upper retina (located between 8:00 and 4:00 clock hours).
- Ability and willingness to comply with post-procedure face-down positioning, steam-roll maneuvers, and scheduled follow-up visits.
Exclusion Criteria:
- Pseudophakic or aphakic status.
- Retinal breaks located in the inferior 4 clock hours (between 4:00 and 8:00 clock hours).
- Multiple retinal breaks spanning more than 1 clock hour.
- Presence of proliferative vitreoretinopathy (PVR) grade C or D.
- Media opacities obstructing adequate visualization of the fundus or preventing effective laser photocoagulation (e.g., severe vitreous hemorrhage or advanced cataract).
- Uncontrolled baseline intraocular pressure or pre-existing advanced glaucoma.
- History of prior vitreoretinal surgery in the study eye.
- Physical, mental, or geographic inability to maintain strict post-procedure positioning or fulfill protocol requirements.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Pneumatic Retinopexy (PnR) Cohort
Phakic adult patients presenting with primary superior rhegmatogenous retinal detachment (RRD) meeting adapted PIVOT eligibility criteria.
All participants underwent standardized pneumatic retinopexy, including anterior chamber paracentesis (0.3 cc), inferotemporal intravitreal 100% C3F8 gas injection (0.7 cc), initial face-down and steam-roll positioning, and postoperative 577-nm yellow argon laser retinopexy with a 360-degree peripheral barrier.
|
Standardized pneumatic retinopexy protocol including pre-gas 577-nm yellow argon laser to non-detached breaks (if applicable), anterior chamber paracentesis (0.3 cc), inferotemporal intravitreal injection of 100% C3F8 gas (0.7 cc), 1 hour of face-down positioning followed by steam-roll maneuver, and postoperative 577-nm yellow argon laser retinopexy with a 360-degree peripheral barrier once retinal reattachment is achieved.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Primary Anatomical Success Rate
기간: 24 months
|
Proportion of patients achieving sustained retinal reattachment following initial pneumatic retinopexy without requiring secondary surgical interventions (such as pars plana vitrectomy or scleral buckling).
|
24 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Juncal VR, Bamakrid M, Jin S, Paracha Q, Ta Kim DT, Marafon SB, Francisconi CLM, Muni RH. Pneumatic Retinopexy in Patients with Primary Rhegmatogenous Retinal Detachment Meeting PIVOT Trial Criteria. Ophthalmol Retina. 2021 Mar;5(3):262-269. doi: 10.1016/j.oret.2020.07.022. Epub 2020 Jul 31.
- Iannetta D, Valsecchi N, Finzi A, Mastropasqua R, Muni RH, Fontana L. Pneumatic retinopexy for primary rhegmatogenous retinal detachment: from a clinical trial to the real-life experience. BMC Ophthalmol. 2024 Jul 16;24(1):287. doi: 10.1186/s12886-024-03559-7.
- Hillier RJ, Felfeli T, Berger AR, Wong DT, Altomare F, Dai D, Giavedoni LR, Kertes PJ, Kohly RP, Muni RH. The Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT). Ophthalmology. 2019 Apr;126(4):531-539. doi: 10.1016/j.ophtha.2018.11.014. Epub 2018 Nov 22.
- Muni RH, Felfeli T, Sadda SR, Juncal VR, Francisconi CLM, Nittala MG, Lindenberg S, Gunnemann F, Berger AR, Wong DT, Altomare F, Giavedoni LR, Kohly RP, Kertes PJ, Sarraf D, Hillier RJ. Postoperative Photoreceptor Integrity Following Pneumatic Retinopexy vs Pars Plana Vitrectomy for Retinal Detachment Repair: A Post Hoc Optical Coherence Tomography Analysis From the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial. JAMA Ophthalmol. 2021 Jun 1;139(6):620-627. doi: 10.1001/jamaophthalmol.2021.0803.
- Chizzolini M, Martini F, Melis R, Montericcio A, Raimondi R, Allegrini D, Romano MR. Pneumatic retinopexy versus scleral buckling for the management of primary rhegmatogenous retinal detachment. Eur J Ophthalmol. 2023 Jan;33(1):498-505. doi: 10.1177/11206721221095041. Epub 2022 Apr 25.
- Roshanshad A, Shirzadi S, Binder S, Arevalo JF. Pneumatic Retinopexy Versus Pars Plana Vitrectomy for the Management of Retinal Detachment: A Systematic Review and Meta-Analysis. Ophthalmol Ther. 2023 Apr;12(2):705-719. doi: 10.1007/s40123-023-00653-9. Epub 2023 Jan 30.
- Shah S, Chou B, Patel M, Watane A, Shah L, Yannuzzi N, Sridhar J. Review and analysis of history and utilization of pneumatic retinopexy after pneumatic retinopexy versus vitrectomy for the management of primary rhegmatogenous retinal detachment outcomes randomized trial (PIVOT). Curr Opin Ophthalmol. 2024 May 1;35(3):217-222. doi: 10.1097/ICU.0000000000001039. Epub 2024 Feb 15.
- Fernandez-Vega Gonzalez A, Muni RH. The history of pneumatic retinopexy: have we come full circle? Acta Ophthalmol. 2022 Feb;100(1):118-120. doi: 10.1111/aos.14876. Epub 2021 Apr 14.
- Ge JY, Teo ZL, Chee ML, Tham YC, Rim TH, Cheng CY, Wong TY; SNEC Surgical Retina Research Group; Wong EYM, Lee SY, Cheung N. International incidence and temporal trends for rhegmatogenous retinal detachment: A systematic review and meta-analysis. Surv Ophthalmol. 2024 May-Jun;69(3):330-336. doi: 10.1016/j.survophthal.2023.11.005. Epub 2023 Nov 23.
- Kuhn F, Aylward B. Rhegmatogenous retinal detachment: a reappraisal of its pathophysiology and treatment. Ophthalmic Res. 2014;51(1):15-31. doi: 10.1159/000355077. Epub 2013 Oct 22.
- Ellakwa AF. Long term results of pneumatic retinopexy. Clin Ophthalmol. 2012;6:55-9. doi: 10.2147/OPTH.S22063. Epub 2012 Jan 9.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PT-CO40
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .