Macular HolesNCT06323902
Autologous Platelet-rich Plasma as a Treatment for Macular Holes
An observational study of Macular Holes and Macular Hole of Left Eye (Disorder), run by Clinica Oftalmologica Paredes at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Holes, Macular Hole of Left Eye (Disorder), Macular Hole of Right Eye (Disorder)
- What is being tested?
- Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteColombia
- Study dates
- 25 Oct 2022to 29 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Clinica Ofalmologica Paredes
Pasto, Departamento de Nariño, 520002
About this study
Official title: Clinical Evidence of Autologous Platelet-Rich Plasma as a Treatment for Macular Holes
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.
Read the 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.
- Being tested
- Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation
- Keywords
- PLATELET RICH PLASMA, PLATELET GROWTH FACTORS, AUTOLOGOUS PLASMA, MACULAR HOLE
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantationProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure
The closure of the macular hole after PRGF membrane implantation was evaluated.
Measured: Follow-up was carried out for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start25 Oct 2022
- Primary completion8 Jun 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Macular HolesStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Oftalmologica Paredes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323902
- Sponsor's protocol ID
- PT-CO39
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the moment there is no plan to share the individual data of participants
Publications
Majumdar S, Tripathy K. Macular Hole. 2023 Aug 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559200/
PubMed 32644626Lyu 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.
PubMed 29862182Shen 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.
PubMed 31914954Cisiecki 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.
PubMed 33728059Buzzi 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.
PubMed 36902837Okonkwo 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.
PubMed 33520129Sanchez-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.
PubMed 35076502Wang 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.
PubMed 37948745Galletero 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.
PubMed 35331671
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evidence of Autologous Platelet-Rich Plasma as a Treatment for Macular Holes
- ClinicalTrials.gov ID
- NCT06323902
- Acronym / sponsor ID
- PT-CO39
- Keywords
- PLATELET RICH PLASMA, PLATELET GROWTH FACTORS, AUTOLOGOUS PLASMA, MACULAR HOLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Clinica Oftalmologica ParedesUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 21 Mar 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with giant full thickness macular hole | – | Procedure: Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation13 patients with a diagnosis of macular hole with a total thickness greater than 400 microns were chosen. Without prior vitreoretinal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
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 |
|---|---|---|
| Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantationAlso: PRGF membrane implantationIn 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. | Procedure or surgery | Patients with giant full thickness macular hole |
Primary outcome
Macular hole closure
Time frame: Follow-up was carried out for 1 year
The closure of the macular hole after PRGF membrane implantation was evaluated.
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 21 Mar 2024.
- Background: PubMed 32644626Majumdar S, Tripathy K. Macular Hole. 2023 Aug 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559200/
- Background: PubMed 29862182Lyu 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.
- Background: PubMed 31914954Shen 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.
- Background: PubMed 33728059Cisiecki 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.
- Background: PubMed 36902837Buzzi 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.
- Background: PubMed 33520129Okonkwo 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.
- Background: PubMed 35076502Sanchez-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.
- Background: PubMed 37948745Wang 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.
- Background: PubMed 35331671Galletero 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.
- Macular HoleLink provided by the sponsor.
- Treatment of refractory giant macular hole by vitrectomy with internal limiting membrane transplantation and autologous bloodLink provided by the sponsor.
- Comparative efficacy evaluation of inverted internal limiting membrane flap technique and internal limiting membrane peeling in large macular holes: a systematic review and meta-analysisLink provided by the sponsor.
- Autologous Lens Capsule Flap Transplantation for Persistent Macular HolesLink provided by the sponsor.
- The Short-Term Results of Autologous Platelet-Rich Plasma as an Adjuvant to Re-Intervention in the Treatment of Refractory Full-Thickness Macular HolesLink provided by the sponsor.
- Autologous Neurosensory Retinal Transplantation: A Report of Three CasesLink provided by the sponsor.
- Individual participant dataSharing planned: No. At the moment there is no plan to share the individual data of participants
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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 Macular Holes and Macular Hole of Left Eye (Disorder), 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 3 inclusion and 3 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 21 Mar 2024. 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?
Macular hole closure (time frame: Follow-up was carried out for 1 year). 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 NCT06323902, which also lists 9 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 21 Mar 2024.