Effect of Dexamethasone Implant on Optic Disc
Sponsor
Bulent Ecevit University (Other)
Overall Status
Completed
CT.gov ID
NCT03927118
Collaborator
(none)
43
1
12
3.6
Study Details
Study Description
Brief Summary
This study evaluates the effect of dexamethasone implant which is an intraocular corticosteroid on the optic nerve fibers. Retinal nerve fiber thicknesses and optic nerve head pitting rates were measured before and 6 months after the injection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Diabetic macular edema is the most frequent ocular complication of diabetes resulting in irreversible loss of vision if untreated. Dexamethasone implant implant is used to treat macular edema due to diabetes. It stay in the vitreous for 6 months after intravitreal administration.
Dexamethasone implant can lead to retinal nerve fiber layer and optic nerve damage by both increasing intraocular pressure and its direct effect on neural tissue during the effective 6-month period.
Study Design
Study Type:
Observational
Actual Enrollment
:
43 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy
Actual Study Start Date
:
Feb 1, 2018
Actual Primary Completion Date
:
Sep 1, 2018
Actual Study Completion Date
:
Jan 31, 2019
Outcome Measures
Primary Outcome Measures
- Peripapillary RNFL thickness measurements [six month]
micrometer
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria
Patients who underwent first time intravitreal injection
Exclusion Criteria
Previously received any surgery
Proliferative diabetic retinopathy
Glaucoma or glaucoma suspicion
Optic disc fatigue
Optic disc edema
Uveitis and media opacity
Blurred of image clarity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zonguldak Bülent Ecevit Üniversitesi. | Zonguldak | Kozlu | Turkey | 67600 |
Sponsors and Collaborators
- Bulent Ecevit University
Investigators
- Study Director: Atilla Alpay, Ass. Prf., Zonguldak Bulent Ecevit University
Study Documents (Full-Text)
None provided.More Information
Publications
- Assmann TS, Brondani LA, Bouças AP, Rheinheimer J, de Souza BM, Canani LH, Bauer AC, Crispim D. Nitric oxide levels in patients with diabetes mellitus: A systematic review and meta-analysis. Nitric Oxide. 2016 Dec 30;61:1-9. doi: 10.1016/j.niox.2016.09.009. Epub 2016 Sep 24. Review.
- Celik M, Cerrah S, Arabul M, Akalin A. Relation of asymmetric dimethylarginine levels to macrovascular disease and inflammation markers in type 2 diabetic patients. J Diabetes Res. 2014;2014:139215. doi: 10.1155/2014/139215. Epub 2014 Apr 3.
- Du JH, Li X, Li R, Xu L, Ma RR, Liu SF, Zhang Z, Sun HZ. Elevation of serum apelin-13 associated with proliferative diabetic retinopathy in type 2 diabetic patients. Int J Ophthalmol. 2014 Dec 18;7(6):968-73. doi: 10.3980/j.issn.2222-3959.2014.06.10. eCollection 2014.
- Ersoy B, Eroğlu N, Çetin M, Onur E, Özkol M, Coşkun Ş. Asymmetric dimethylarginine levels and diabetes duration: Relationship with measures of subclinical atherosclerosis and cardiac function in children and adolescents with Type 1 diabetes. Diab Vasc Dis Res. 2018 May;15(3):196-203. doi: 10.1177/1479164118757921. Epub 2018 Mar 2.
- Franceschelli S, Ferrone A, Pesce M, Riccioni G, Speranza L. Biological functional relevance of asymmetric dimethylarginine (ADMA) in cardiovascular disease. Int J Mol Sci. 2013 Dec 16;14(12):24412-21. doi: 10.3390/ijms141224412.
- Heunisch F, Chaykovska L, von Einem G, Alter M, Dschietzig T, Kretschmer A, Kellner KH, Hocher B. ADMA predicts major adverse renal events in patients with mild renal impairment and/or diabetes mellitus undergoing coronary angiography. Medicine (Baltimore). 2017 Feb;96(6):e6065. doi: 10.1097/MD.0000000000006065.
- Lin KY, Ito A, Asagami T, Tsao PS, Adimoolam S, Kimoto M, Tsuji H, Reaven GM, Cooke JP. Impaired nitric oxide synthase pathway in diabetes mellitus: role of asymmetric dimethylarginine and dimethylarginine dimethylaminohydrolase. Circulation. 2002 Aug 20;106(8):987-92.
- Liu L, Wu X, Liu L, Geng J, Yuan Z, Shan Z, Chen L. Prevalence of diabetic retinopathy in mainland China: a meta-analysis. PLoS One. 2012;7(9):e45264. doi: 10.1371/journal.pone.0045264. Epub 2012 Sep 20.
- Lluch P, Segarra G, Medina P. Asymmetric dimethylarginine as a mediator of vascular dysfunction in cirrhosis. World J Gastroenterol. 2015 Aug 28;21(32):9466-75. doi: 10.3748/wjg.v21.i32.9466. Review.
- Marcovecchio ML, Widmer B, Turner C, Dunger DB, Dalton RN. Asymmetric dimethylarginine in young people with Type 1 diabetes: a paradoxical association with HbA(1c). Diabet Med. 2011 Jun;28(6):685-91. doi: 10.1111/j.1464-5491.2011.03252.x.
- Suwanpradid J, Rojas M, Behzadian MA, Caldwell RW, Caldwell RB. Arginase 2 deficiency prevents oxidative stress and limits hyperoxia-induced retinal vascular degeneration. PLoS One. 2014 Nov 6;9(11):e110604. doi: 10.1371/journal.pone.0110604. eCollection 2014.
- Yin YL, Zhu ML, Wan J, Zhang C, Pan GP, Lu JX, Ping S, Chen Y, Zhao FR, Yu HY, Guo T, Jian X, Liu LY, Zhang JN, Wan GR, Wang SX, Li P. Traditional Chinese medicine xin-mai-jia recouples endothelial nitric oxide synthase to prevent atherosclerosis in vivo. Sci Rep. 2017 Mar 2;7:43508. doi: 10.1038/srep43508.
Responsible Party:
Atilla Alpay,
Associate professor,
Bulent Ecevit University
ClinicalTrials.gov Identifier:
NCT03927118
Other Study ID Numbers:
- BulentEU2
First Posted:
Apr 25, 2019
Last Update Posted:
May 13, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Atilla Alpay,
Associate professor,
Bulent Ecevit University
Additional relevant MeSH terms: