Clinical trial NCT03786146: Changes in Retinal Nerve Fiber Layer Thickness Detected by OCT in Diabetic Retinopathy After Panretinal Photocoagulation
Official title: Changes in Retinal Nerve Fiber Layer Thickness Detected by Optical Coherence Tomography in Diabetic Retinopathy After Panretinal Photocoagulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
timeFrame: 0 (before laser treatment ).
measure: Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
timeFrame: 1 month post laser treatment.
measure: Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
timeFrame: 3 months post laser treatment.
measure: Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT) and expressed in micrometers.
timeFrame: 6 months post laser treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: researcher in Assiut university
name: rania goda
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: ehab wasfi
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ali Netag
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Kamel Abd Elnaser
role: STUDY_CHAIR
References:
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
citation: 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.
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.
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. doi: 10.1167/iovs.03-0514.
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.
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.