Autologous Platelet-rich Plasma as a Treatment for Macular Holes

NCT06323902 | Completed

• 1 other identifier: PT-CO39
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

For a series of patients with full-thickness macular hole, an autologous plasma rich in growth factors was developed in the form of a clot and applied to the retinal defect. These patients were followed up for a period of one year, obtaining substantial improvement both anatomically and functionally.

Conditions

Macular Holes; Macular Hole of Left Eye (Disorder); Macular Hole of Right Eye (Disorder)

Keywords

PLATELET RICH PLASMA; PLATELET GROWTH FACTORS; AUTOLOGOUS PLASMA; MACULAR HOLE

Outcome Measures

Primary Outcomes (1)

• Macular hole closure

  The closure of the macular hole after PRGF membrane implantation was evaluated.

  Follow-up was carried out for 1 year

Study Arms (1)

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

Procedure: Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation

Interventions

Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation PROCEDURE

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.

Also known as: PRGF membrane implantation

Patients with giant full thickness macular hole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

13 patients were chosen with a diagnosis of macular hole with a total thickness greater than 400 microns, over 18 years of age, with no history of previous vitreretinal surgery or with other retinal pathologies. The triggering factors in 46% were due to the presence of an Epiretinal Membrane (6 cases) and 54% were due to vitreomacular traction (7 cases).

You may qualify if:

• Patients with a diagnosis of macular hole with a total thickness greater than 400 microns
• Patients without prior vitreoretinal surgery
• Patients over 18 years of age

You may not qualify if:

• Patients under 18 years of age
• Patients with previous vitreoretinal surgery
• Patients who had other additional retinal pathologies (diabetic retinopathy, hypertensive retinopathy, vascular retinal occlusions, retinal detachment, etc.)

Sponsors & Collaborators

• Clinica Oftalmologica Paredes: lead

Study Sites (1)

Clinica Ofalmologica Paredes

Pasto, Departamento de Nariño, 520002, Colombia

Location

Related Publications (9)

• 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/

  PMID: 32644626 BACKGROUND

• 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.

  PMID: 29862182 BACKGROUND

• 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.

  PMID: 31914954 BACKGROUND

• 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.

  PMID: 33728059 BACKGROUND

• 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.

  PMID: 36902837 BACKGROUND

• 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.

  PMID: 33520129 BACKGROUND

• 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.

  PMID: 35076502 BACKGROUND

• 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.

  PMID: 37948745 BACKGROUND

• 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.

  PMID: 35331671 BACKGROUND

Related Links

• Macular Hole
• 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

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: October 25, 2022
• Primary Completion: June 8, 2023
• Study Completion: February 29, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)