Autologous Platelet-rich Plasma as a Treatment for Macular Holes

Completed

• Conditions: Macular Holes; Macular Hole of Left Eye (Disorder); Macular Hole of Right Eye (Disorder)
• Interventions: Procedure: Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation

• Registration Number: NCT06323902
• Lead Sponsor: Clinica Oftalmologica Paredes

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.

Detailed Description

A prospective observational study was carried out. Obtaining approval from the Institutional Ethics Committee at the Paredes Ophthalmology Clinic, in the city of Pasto - Colombia. This study adhered to the principles of the Declaration of Helsinki. 13 patients with a diagnosis of macular hole with a total thickness greater than 400 microns were chosen. The previous evaluation included a history and complete ophthalmological examination, uncorrected or better corrected visual acuity, optical coherence tomography - Optovue OCT and in some cases retinal photographs on the Eidon FA equipment. The inclusion criteria were: Patients without previous vitreoretinal surgery for macular hole, large full thickness macular hole.

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.

Study Timeline

• Study Start: 2022-10-25
• Primary Completion: 2023-06-08
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 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

Exclusion Criteria

• 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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with giant full thickness macular hole	Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation	13 patients with a diagnosis of macular hole with a total thickness greater than 400 microns were chosen. Without prior vitreoretinal surgery

Primary Outcome Measures

Name	Time	Method
Macular hole closure	Follow-up was carried out for 1 year	The closure of the macular hole after PRGF membrane implantation was evaluated.

Trial Locations

Locations (1)

Clinica Ofalmologica Paredes; 🇨🇴 Pasto, Nariño, Colombia