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AzTrials

Diabetic Macular EdemaNCT06316388

Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema

An observational study of Diabetic Macular Edema, run by Rehab Azzam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) and anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema (TDME) . 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
vitrectomy
Type of treatment
Surgery or procedure
How many people
21 participants
Where
No sites listed yet
Study dates
10 Mar 2024to 11 Mar 2025
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
  • No healthy volunteers
  • Adult, Older adult

Study population: eyes with tractional diabetic macular edema

Who may be able to join

  • Age ≥18 years; type 1 or 2 diabetes
  • TDME as the indication for vitrectomy; central foveal thickness (CFT) ≥300 µm as measured by spectral-domain optical coherence tomography (SD-OCT) , We defined VMIA on OCT as ERM, anomalous vitreomacular adhesions, or both , ), and possible visual acuity impairment attributed to foveal thickening due to DME.

Who cannot join

  • A history of other retinal diseases; or active ocular inflammation or infection or glaucoma .
  • Eyes with macular edema from etiologies other than diabetes
  • Dense refractive media opacity before and after surgery, such as dense cataract, vitreous hemorrhage which can conceal fundus visualization and OCT measurements
  • Central retinal ischemia detected by intravenous fluorescein angiograms.
  • A history of vitrectomy
  • A visual acuity worse than 1\60 and the duration of tractional ERM is more than 12 months.

Trial locations and contacts

No sites are listed yet.

rehab azzam, master contact

01060391518

rehabazzam14111994@gmail.com

About this study

Official title: Anatomical and Functional Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema

  1. assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) and anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema (TDME) .
  2. To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME.
Read the detailed description

Diabetic retinopathy (DR) is one of the leading causes of vision loss worldwide [1]. In 2010, DR affected more than 93 million individuals worldwide, 28 million of whom experienced vision-threatening DR[2].

Diabetic macular edema (DME) is a common cause of visual loss in diabetic retinopathy (DR) and is a complication in any stages of DR including proliferative diabetic retinopathy (PDR)[3].

The terms vitreous traction maculopathy, vitreous induced diabetic macular edema and maculopathy due to posterior hyaloid traction are synonymous and describe a pattern of diabetic maculopathy which is characterized by: (1) The absence of complete posterior vitreous detachment; (2) An increased retinal thickness in the center of the macula, and (3) a characteristic reflex of the vitreoretinal interface[4]. there are multiple factors in the vitreomacular interface including ERM, taut posterior cortices, vitreoschisis, PVD, and adhesions [5]. Anomalous PVD generates antero-posterior and tangential traction forces at the vitreo-retinal interface that act upon the inner and outer retinal layers [6]. Until recently, the only treatment option available for VMA was vitrectomy[7].

Few studies have used the multifocal electroretinogram (mfERG) technique to investigate the effects of vitrectomy on macular visual function for DME [8]. Mf-ERG is an objective electrophysiologic technique that measures the electrical changes in the central retinal area. This technique accurately assess the electrophysiologic activity in multiple retinal areas, and gives us a topographic charting of retinal function [9] .

Being tested
vitrectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vitrectomyProcedure or surgery

    pars plana vitrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assessment the outcomes of vitrectomy on retinal function in patients with tractional diabetic macular edema

    assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) in patients with tractional diabetic macular edema

    Measured: baseline

  2. assessment the outcomes of vitrectomy on retinal anatomy in patients with tractional diabetic macular edema

    assessment the outcomes of vitrectomy on retinal anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema

    Measured: Baseline

Secondary outcomes (1)

  1. correlation CDVA with mf-ERG and OCT finding

    To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start10 Mar 2024 (estimated)
  3. Primary completion10 Mar 2025 (estimated)
  4. Study completion11 Mar 2025 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316388
Sponsor's protocol ID
TDME
Status last verified
Mar 2024
First submitted
9 Mar 2024
Last updated
18 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015 Sep 30;2:17. doi: 10.1186/s40662-015-0026-2. eCollection 2015.

    PubMed 26605370

  • Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1.

    PubMed 22301125

  • Romero-Aroca P, Baget-Bernaldiz M, Pareja-Rios A, Lopez-Galvez M, Navarro-Gil R, Verges R. Diabetic Macular Edema Pathophysiology: Vasogenic versus Inflammatory. J Diabetes Res. 2016;2016:2156273. doi: 10.1155/2016/2156273. Epub 2016 Sep 28.

    PubMed 27761468

  • Lewis H, Abrams GW, Blumenkranz MS, Campo RV. Vitrectomy for diabetic macular traction and edema associated with posterior hyaloidal traction. Ophthalmology. 1992 May;99(5):753-9. doi: 10.1016/s0161-6420(92)31901-3.

    PubMed 1594222

  • Agarwal D, Gelman R, Prospero Ponce C, Stevenson W, Christoforidis JB. The Vitreomacular Interface in Diabetic Retinopathy. J Ophthalmol. 2015;2015:392983. doi: 10.1155/2015/392983. Epub 2015 Sep 3.

    PubMed 26425349

  • Duker JS, Kaiser PK, Binder S, de Smet MD, Gaudric A, Reichel E, Sadda SR, Sebag J, Spaide RF, Stalmans P. The International Vitreomacular Traction Study Group classification of vitreomacular adhesion, traction, and macular hole. Ophthalmology. 2013 Dec;120(12):2611-2619. doi: 10.1016/j.ophtha.2013.07.042. Epub 2013 Sep 17.

    PubMed 24053995

  • Yamamoto T, Akabane N, Takeuchi S. Vitrectomy for diabetic macular edema: the role of posterior vitreous detachment and epimacular membrane. Am J Ophthalmol. 2001 Sep;132(3):369-77. doi: 10.1016/s0002-9394(01)01050-9.

    PubMed 11530050

  • Massin P, Audren F, Haouchine B, Erginay A, Bergmann JF, Benosman R, Caulin C, Gaudric A. Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial. Ophthalmology. 2004 Feb;111(2):218-24; discussion 224-5. doi: 10.1016/j.ophtha.2003.05.037.

    PubMed 15019365

  • Dowler JG. Laser management of diabetic retinopathy. J R Soc Med. 2003 Jun;96(6):277-9. doi: 10.1177/014107680309600605. No abstract available.

    PubMed 12782691

  • Khattab AAA, Ahmed MM, Hammed AH. Pars plana vitrectomy for tractional diabetic macular edema with or without internal limiting membrane peeling. Med Hypothesis Discov Innov Ophthalmol. 2022 Dec 3;11(3):110-118. doi: 10.51329/mehdiophthal1454. eCollection 2022 Fall.

    PubMed 37641643

  • Marmor MF, Hood DC, Keating D, Kondo M, Seeliger MW, Miyake Y; International Society for Clinical Electrophysiology of Vision. Guidelines for basic multifocal electroretinography (mfERG). Doc Ophthalmol. 2003 Mar;106(2):105-15. doi: 10.1023/a:1022591317907. No abstract available.

    PubMed 12678274

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Macular Edema, run by Rehab Azzam.

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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact rehab azzam, master (01060391518, rehabazzam14111994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assessment the outcomes of vitrectomy on retinal function in patients with tractional diabetic macular edema (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT06316388, which also lists 11 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 18 Mar 2024.

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