Changes in Retinal Nerve Fiber Layer Thickness Detected by OCT in Diabetic Retinopathy After Panretinal Photocoagulation

NCT03786146 | Unknown

• 1 other identifier: RNFL in diabetic after PRP
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic retinopathy. It is recognized that laser expansion into the retina may be associated with photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss. Panretinal photocoagulation can cause alteration in retinal vascular permeability therefore, retinal thickness may be increased including retinal nerve fiber layer. On the contrary, it can damage retinal cells including ganglion cells, which may decrease the retinal nerve fiber layer thickness in the latter follow up period. Peripapillary retinal nerve fiber layer can be measured by optical coherence tomography which is a non-invasive technique for obtaining high resolution cross sectional images of a tissue.

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (4)

• Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.

  A 3.4 mm OCT circular scan will be positioned around the optic nerve head.

  0 (before laser treatment ).

• Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.

  A 3.4 mm OCT circular scan will be positioned around the optic nerve head.

  1 month post laser treatment.

• Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.

  A 3.4 mm OCT circular scan will be positioned around the optic nerve head.

  3 months post laser treatment.

• Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.

  A 3.4 mm OCT circular scan will be positioned around the optic nerve head.

  6 months post laser treatment.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be carried out on patients with a clinical diagnosis of proliferative diabetic retinopathy treated by panretinal photocoagulation.

You may qualify if:

• Patients with a clinical diagnosis of proliferative diabetic retinopathy.
• Treated by panretinal photocoagulation.
• Age between 40-70 years old.

You may not qualify if:

• Patients with densely opaque media (as dense cataract or vitreous hemorrhage).
• Glaucomatous patients.
• Any other associated retinopathy.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Wagdy F, El Sobky H, Sarhan AE-R, Hafez M. Evaluation of retinal nerve fiber layer thickness in diabetic retinopathy by optical coherence tomography after full scatter panretinal argon laser photocoagulation. J Egypt Ophthalmol Soc [Internet]. 2013 Jul 1;106(3):153-8. Available from: http://www.jeos.eg.net/article.asp?issn=2090-0686

  BACKGROUND

• Kim HY, Cho HK. Peripapillary retinal nerve fiber layer thickness change after panretinal photocoagulation in patients with diabetic retinopathy. Korean J Ophthalmol. 2009 Mar;23(1):23-6. doi: 10.3341/kjo.2009.23.1.23. Epub 2009 Mar 9.

  PMID: 19337475 BACKGROUND

• Kim J, Woo SJ, Ahn J, Park KH, Chung H, Park KH. Long-term temporal changes of peripapillary retinal nerve fiber layer thickness before and after panretinal photocoagulation in severe diabetic retinopathy. Retina. 2012 Nov-Dec;32(10):2052-60. doi: 10.1097/IAE.0b013e3182562000.

  PMID: 23099450 BACKGROUND

• Paunescu LA, Schuman JS, Price LL, Stark PC, Beaton S, Ishikawa H, Wollstein G, Fujimoto JG. Reproducibility of nerve fiber thickness, macular thickness, and optic nerve head measurements using StratusOCT. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1716-24. doi: 10.1167/iovs.03-0514.

  PMID: 15161831 BACKGROUND

• Lim MC, Tanimoto SA, Furlani BA, Lum B, Pinto LM, Eliason D, Prata TS, Brandt JD, Morse LS, Park SS, Melo LA Jr. Effect of diabetic retinopathy and panretinal photocoagulation on retinal nerve fiber layer and optic nerve appearance. Arch Ophthalmol. 2009 Jul;127(7):857-62. doi: 10.1001/archophthalmol.2009.135.

  PMID: 19597104 BACKGROUND

• Muqit MM, Wakely L, Stanga PE, Henson DB, Ghanchi FD. Effects of conventional argon panretinal laser photocoagulation on retinal nerve fibre layer and driving visual fields in diabetic retinopathy. Eye (Lond). 2010 Jul;24(7):1136-42. doi: 10.1038/eye.2009.308. Epub 2009 Dec 18.

  PMID: 20019760 BACKGROUND

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• rania goda

  researcher in Assiut university

  PRINCIPAL INVESTIGATOR

• ehab wasfi

  Assiut University

  STUDY DIRECTOR

• Ali Netag

  Assiut University

  STUDY DIRECTOR

• Kamel Abd Elnaser

  Assiut University

  STUDY CHAIR

Central Study Contacts

ehab wasfi, assist prof

CONTACT

00201000373344; ehabinegypt@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 24, 2018
• Study Start: January 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 24, 2018

Record last verified: 2018-12