Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema

NCT06316388 | Not Yet Recruiting

• 1 other identifier: TDME
• Study Type: observational
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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

  baseline

• 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

  Baseline

Secondary Outcomes (1)

• correlation CDVA with mf-ERG and OCT finding

  baseline

Interventions

vitrectomy PROCEDURE

pars plana vitrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

eyes with tractional diabetic macular edema

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rehab Azzam: lead

Related Publications (11)

• 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.

  PMID: 26605370 BACKGROUND

• 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.

  PMID: 22301125 BACKGROUND

• 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.

  PMID: 27761468 BACKGROUND

• 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.

  PMID: 1594222 BACKGROUND

• 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.

  PMID: 26425349 BACKGROUND

• 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.

  PMID: 24053995 BACKGROUND

• 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.

  PMID: 11530050 BACKGROUND

• 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.

  PMID: 15019365 BACKGROUND

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

  PMID: 12782691 BACKGROUND

• 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.

  PMID: 37641643 BACKGROUND

• 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.

  PMID: 12678274 BACKGROUND

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• ehab wasfi, prof

  Assiut University

  STUDY CHAIR

Central Study Contacts

rehab azzam, master

CONTACT

01060391518; rehabazzam14111994@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 18, 2024
• Study Start: March 10, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 11, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03