Autologous Platelet-rich Plasma as a Treatment for Macular Holes
NCT ID: NCT06323902
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
13 participants
OBSERVATIONAL
2022-10-25
2024-02-29
Brief Summary
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Detailed Description
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During the consultation prior to scheduling the surgical procedure and on the day of the procedure, each patient was given a clear explanation about the intervention, doubts were resolved, and informed consent was signed in each case.
Following the institutional protocol for obtaining the platelet-rich plasma membrane, whole blood was obtained from each patient in 2 tubes with 3.2% sodium citrate, used as an anticoagulant. Subsequently, the samples were taken to be centrifuged at 3200 rpm for a period of 15 minutes, from here approximately 1.5 cc of plasma was obtained from each tube, without aspirating the white phase (leukocytes) or the red phase (erythrocytes), the plasma . obtained from each tube was placed in a single tube without anticoagulant and centrifuged again at 2700 rpm for a period of 7 minutes. Once the second centrifugation was completed, between 1 and 1.5 cc of the lower third of the plasma was obtained in a first syringe, to which 10% calcium gluconate was added with a ratio of 0.05 cc of calcium gluconate for every 1.5 cc plasma. Once the components are mixed, the plasma is spread with calcium gluconate on a petri dish forming a layer of approximately 2 mm. It is left covered at room temperature for approximately 30 minutes. The formation of clots in the layer is verified. plasma and went to the surgery room. The entire procedure was carried out under rigorous asepsis and sterility measures. In the operating room through pars plana vitrectomy after having completed the complete air exchange, with the help of a Backwash Charles cannula, the PRGF membrane is placed in the macular hole and C3F8 gas is left in the posterior chamber, the first hour in the recumbent position. supine and subsequently face down during the first postoperative week.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with giant full thickness macular hole
13 patients with a diagnosis of macular hole with a total thickness greater than 400 microns were chosen. Without prior vitreoretinal surgery
Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation
In the operating room through pars plana vitrectomy after having completed the complete air exchange, with the help of a Backwash Charles cannula, the PRGF membrane is placed in the macular hole and C3F8 gas is left in the posterior chamber, the first hour in the recumbent position. supine and subsequently face down during the first postoperative week.
Interventions
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Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation
In the operating room through pars plana vitrectomy after having completed the complete air exchange, with the help of a Backwash Charles cannula, the PRGF membrane is placed in the macular hole and C3F8 gas is left in the posterior chamber, the first hour in the recumbent position. supine and subsequently face down during the first postoperative week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients without prior vitreoretinal surgery
* Patients over 18 years of age
Exclusion Criteria
* Patients with previous vitreoretinal surgery
* Patients who had other additional retinal pathologies (diabetic retinopathy, hypertensive retinopathy, vascular retinal occlusions, retinal detachment, etc.)
18 Years
ALL
Yes
Sponsors
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Clinica Oftalmologica Paredes
OTHER
Responsible Party
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Locations
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Clinica Ofalmologica Paredes
Pasto, Departamento de Nariño, Colombia
Countries
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References
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Majumdar S, Tripathy K. Macular Hole. 2023 Aug 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559200/
Lyu WJ, Ji LB, Xiao Y, Fan YB, Cai XH. Treatment of refractory giant macular hole by vitrectomy with internal limiting membrane transplantation and autologous blood. Int J Ophthalmol. 2018 May 18;11(5):818-822. doi: 10.18240/ijo.2018.05.17. eCollection 2018.
Shen Y, Lin X, Zhang L, Wu M. Comparative efficacy evaluation of inverted internal limiting membrane flap technique and internal limiting membrane peeling in large macular holes: a systematic review and meta-analysis. BMC Ophthalmol. 2020 Jan 8;20(1):14. doi: 10.1186/s12886-019-1271-2.
Cisiecki S, Boninska K, Bednarski M. Autologous Lens Capsule Flap Transplantation for Persistent Macular Holes. J Ophthalmol. 2021 Feb 27;2021:8148792. doi: 10.1155/2021/8148792. eCollection 2021.
Buzzi M, Parisi G, Marolo P, Gelormini F, Ferrara M, Raimondi R, Allegrini D, Rossi T, Reibaldi M, Romano MR. The Short-Term Results of Autologous Platelet-Rich Plasma as an Adjuvant to Re-Intervention in the Treatment of Refractory Full-Thickness Macular Holes. J Clin Med. 2023 Mar 4;12(5):2050. doi: 10.3390/jcm12052050.
Okonkwo ON, Hassan AO, Akanbi T. Autologous Neurosensory Retinal Transplantation: A Report of Three Cases. J Ophthalmic Vis Res. 2021 Jan 20;16(1):68-76. doi: 10.18502/jovr.v16i1.8252. eCollection 2021 Jan-Mar.
Sanchez-Avila RM, Robayo-Esper CA, Villota-Deleu E, Fernandez-Vega Sanz A, Fernandez-Vega Gonzalez A, de la Sen-Corcuera B, Anitua E, Merayo-Lloves J. Plasma Rich in Growth Factors in Macular Hole Surgery. Clin Pract. 2022 Jan 10;12(1):57-69. doi: 10.3390/clinpract12010007.
Wang J, Rodriguez SH, Xiao J, Luo W, Gonnah R, Shaw L, Dao D, Schechet SA, Mackin AG, Komati R, Skondra D. FULL-THICKNESS MACULAR HOLE CLOSURE WITH TOPICAL MEDICAL THERAPY. Retina. 2024 Mar 1;44(3):392-399. doi: 10.1097/IAE.0000000000003988.
Galletero Pandelo L, Olaso Fernandez H, Sanchez Aparicio JA, Rodriguez Vidal C, Martinez-Alday N. Results of large macular hole surgery using different interposition techniques. A report on 9 cases. Arch Soc Esp Oftalmol (Engl Ed). 2022 Aug;97(8):457-463. doi: 10.1016/j.oftale.2022.03.010. Epub 2022 Mar 21.
Related Links
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Treatment of refractory giant macular hole by vitrectomy with internal limiting membrane transplantation and autologous blood
Comparative efficacy evaluation of inverted internal limiting membrane flap technique and internal limiting membrane peeling in large macular holes: a systematic review and meta-analysis
Autologous Lens Capsule Flap Transplantation for Persistent Macular Holes
The Short-Term Results of Autologous Platelet-Rich Plasma as an Adjuvant to Re-Intervention in the Treatment of Refractory Full-Thickness Macular Holes
Autologous Neurosensory Retinal Transplantation: A Report of Three Cases
Plasma Rich in Growth Factors in Macular Hole Surgery
FULL-THICKNESS MACULAR HOLE CLOSURE WITH TOPICAL MEDICAL THERAPY
Results of large macular hole surgery using different interposition techniques. A report on 9 cases
Other Identifiers
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PT-CO39
Identifier Type: -
Identifier Source: org_study_id
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