An observational study in Macular Holes, Macular Hole of Left Eye (Disorder) and Macular Hole of Right Eye (Disorder), sponsored by Clinica Oftalmologica Paredes. Completed at 1 site in Colombia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Clinica Oftalmologica Paredes · Observational
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.
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.
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).
Exclusion Criteria:
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
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
Macular hole closure
The closure of the macular hole after PRGF membrane implantation was evaluated.
Time frame: Follow-up was carried out for 1 year
Plan to share: No — At the moment there is no plan to share the individual data of participants
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Clinica Oftalmologica Paredes