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

Retinal Disease Clinical Trial

Official title:

Changes in Retinal Nerve Fiber Layer Thickness Detected by Optical Coherence Tomography in Diabetic Retinopathy After Panretinal Photocoagulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03786146
• Other study ID #: RNFL in diabetic after PRP
• Status: Not yet recruiting
• Start date: January 1, 2019
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: Assiut University
• Contact: ehab wasfi, assist prof
• Phone: 00201000373344
• Email: ehabinegypt[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Pre laser assessment:

• Assessment of medical and family history

• Refraction and best corrected visual acuity

• Anterior segment examination using binocular slit lamp bi-microscopy.

• Posterior segment examination.

• OCT scan of peripapillary area

Post laser assessment ( at 1,3 and 6 months):

• Refraction and best corrected visual acuity.

• Anterior segment examination using binocular slit lamp bi-microscopy.

• Posterior segment examination.

• OCT scan of peripapillary area.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with a clinical diagnosis of proliferative diabetic retinopathy.

• Treated by panretinal photocoagulation.

• Age between 40-70 years old.

Exclusion Criteria:

• Patients with densely opaque media (as dense cataract or vitreous hemorrhage).

• Glaucomatous patients.

• Any other associated retinopathy.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Disease
• Retinal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ).
Primary	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.
Primary	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.
Primary	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.