Rhegmatogenous Retinal DetachmentNCT07794163
Anatomical and Functional Outcomes of Pneumatic Retinopexy for Retinal Detachment: A 2-Year Case Series
An observational study of Rhegmatogenous Retinal Detachment and Retinal Detachment, run by Clinica Oftalmologica Paredes at 1 site in Colombia.
Trial summary
The goal of this observational study is to evaluate the 2-year anatomical and functional outcomes of pneumatic retinopexy in phakic adult patients with superior rhegmatogenous retinal detachment meeting adapted PIVOT eligibility criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment, Retinal Detachment
- What is being tested?
- Pneumatic Retinopexy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteColombia
- Study dates
- 6 Jun 2020to 7 Apr 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Phakic adult patients presenting with primary superior rhegmatogenous retinal detachment (RRD) evaluated and treated at the retina service of Clínica Oftalmológica Paredes in Pasto, Colombia, who met adapted PIVOT trial eligibility criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Clínica Oftalmológica Paredes
Pasto, Departamento de Nariño, 520002
About this study
Official title: 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
The goal of this observational study is to evaluate the 2-year anatomical and functional outcomes of pneumatic retinopexy in phakic adult patients with superior rhegmatogenous retinal detachment meeting adapted PIVOT eligibility criteria. The main questions it aims to answer are to determine the primary anatomical success rate over 24 months-defined as sustained retinal reattachment without secondary vitrectomy or scleral buckling-and to evaluate long-term visual acuity outcomes and structural macular integrity measured by OCT. As a single-arm observational case series, participants undergo baseline ophthalmic evaluation (BCVA, OCT, and fundus photography), followed by a standardized outpatient procedure consisting of anterior chamber paracentesis (0.3 cc), inferotemporal intravitreal 100% C3F8 gas injection (0.7 cc), face-down positioning followed by the steam-roll maneuver, postoperative 577-nm yellow laser retinopexy with a 360° peripheral barrier upon reattachment, and protocolized follow-up evaluations on Day 1, at 3 weeks, 6 weeks, 3 months, and up to 24 months.
Read the detailed description
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.
- Being tested
- Pneumatic Retinopexy
- Keywords
- Pneumatic Retinopexy, Retinal Tear, Laser Retinopexy, PIVOT Criteria, C3F8 Gas, Anatomic Outcomes, Visual Acuity
- Medical subject headings
- Retinal Detachment, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic RetinopexyProcedure or surgery
Also called PnR, Pneumoretinopexia, C3F8 gas injection and laser retinopexy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pneumatic Retinopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Anatomical Success Rate
Proportion of patients achieving sustained retinal reattachment following initial pneumatic retinopexy without requiring secondary surgical interventions (such as pars plana vitrectomy or scleral buckling).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start6 Jun 2020
- Primary completion11 Nov 2023
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Rhegmatogenous Retinal DetachmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Clinica Oftalmologica Paredes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Andrés Noguera Fuertes, Clinica Oftalmologica Paredes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794163
- Sponsor's protocol ID
- PT-CO40
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared in an open data repository. However, de-identified participant data and protocol details can be made available by the corresponding author upon reasonable academic request.
Publications
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.
PubMed 32739607Iannetta 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.
PubMed 39014314Hillier 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.
PubMed 30468761Muni 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.
PubMed 33885738Chizzolini 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.
PubMed 35469453Roshanshad 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.
PubMed 36717526Shah 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.
PubMed 38364771Fernandez-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.
PubMed 33855814Ge 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.
PubMed 38000699Kuhn 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.
PubMed 24158005Ellakwa AF. Long term results of pneumatic retinopexy. Clin Ophthalmol. 2012;6:55-9. doi: 10.2147/OPTH.S22063. Epub 2012 Jan 9.
PubMed 22275808
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07794163
- Acronym / sponsor ID
- PT-CO40
- Keywords
- Pneumatic Retinopexy, Retinal Tear, Laser Retinopexy, PIVOT Criteria, C3F8 Gas, Anatomic Outcomes, Visual Acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Clinica Oftalmologica ParedesUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 31 Aug 2026 (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.
The goal of this observational study is to evaluate the 2-year anatomical and functional outcomes of pneumatic retinopexy in phakic adult patients with superior rhegmatogenous retinal detachment meeting adapted PIVOT eligibility criteria. The main questions it aims to answer are to determine the primary anatomical success rate over 24 months-defined as sustained retinal reattachment without secondary vitrectomy or scleral buckling-and to evaluate long-term visual acuity outcomes and structural macular integrity measured by OCT. As a single-arm observational case series, participants undergo baseline ophthalmic evaluation (BCVA, OCT, and fundus photography), followed by a standardized outpatient procedure consisting of anterior chamber paracentesis (0.3 cc), inferotemporal intravitreal 100% C3F8 gas injection (0.7 cc), face-down positioning followed by the steam-roll maneuver, postoperative 577-nm yellow laser retinopexy with a 360° peripheral barrier upon reattachment, and protocolized follow-up evaluations on Day 1, at 3 weeks, 6 weeks, 3 months, and up to 24 months.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumatic Retinopexy (PnR) Cohort | – | Procedure: Pneumatic RetinopexyPhakic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Phakic adult patients presenting with primary superior rhegmatogenous retinal detachment (RRD) evaluated and treated at the retina service of Clínica Oftalmológica Paredes in Pasto, Colombia, who met adapted PIVOT trial eligibility criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
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 |
|---|---|---|
| Pneumatic RetinopexyAlso: PnR, Pneumoretinopexia, C3F8 gas injection and laser retinopexyStandardized 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. | Procedure or surgery | Pneumatic Retinopexy (PnR) Cohort |
Primary outcome
Primary Anatomical Success Rate
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 32739607Juncal 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.
- Results publication: PubMed 39014314Iannetta 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.
- Results publication: PubMed 30468761Hillier 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.
- Results publication: PubMed 33885738Muni 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.
- Results publication: PubMed 35469453Chizzolini 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.
- Results publication: PubMed 36717526Roshanshad 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.
- Results publication: PubMed 38364771Shah 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.
- Results publication: PubMed 33855814Fernandez-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.
- Results publication: PubMed 38000699Ge 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.
- Results publication: PubMed 24158005Kuhn 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.
- Results publication: PubMed 22275808Ellakwa AF. Long term results of pneumatic retinopexy. Clin Ophthalmol. 2012;6:55-9. doi: 10.2147/OPTH.S22063. Epub 2012 Jan 9.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared in an open data repository. However, de-identified participant data and protocol details can be made available by the corresponding author upon reasonable academic request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhegmatogenous Retinal Detachment and Retinal Detachment, run by Clinica Oftalmologica Paredes at 1 site in Colombia.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 31 Aug 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Anatomical Success Rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07794163, which also lists 11 linked publications.
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 31 Aug 2026.