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

NCT ID: NCT03786146

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Retinal Disease

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Rania M. Goda

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rania goda

Role: PRINCIPAL_INVESTIGATOR

researcher in Assiut university

ehab wasfi

Role: STUDY_DIRECTOR

Assiut University

Ali Netag

Role: STUDY_DIRECTOR

Assiut University

Kamel Abd Elnaser

Role: STUDY_CHAIR

Assiut University

Central Contacts

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ehab wasfi, assist prof

Role: CONTACT

Phone: 00201000373344

Email: [email protected]

References

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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

Reference Type 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.

Reference Type BACKGROUND
PMID: 19337475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23099450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15161831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19597104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20019760 (View on PubMed)

Other Identifiers

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RNFL in diabetic after PRP

Identifier Type: -

Identifier Source: org_study_id