Senile Cataract Clinical Trial
Official title:
Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction in Management of Senile Cataract
NCT number | NCT03262285 |
Other study ID # | CECLPEECCE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | January 15, 2021 |
Verified date | May 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
the investigators will compare between the endothelial cell loss after phacoemulsification and extracapsular cataract extraction in management of senile cataract
Status | Completed |
Enrollment | 70 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 70 Years |
Eligibility | Inclusion Criteria: - Cases of senile cataract of both sexes will be included in this study Exclusion Criteria: - Corneal endothelial pathologies such as Fuch's dystrophy - Complicated cataract - Cataract with history of trauma - Coexisting eye pathology |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut university | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Bourne RR, Minassian DC, Dart JK, Rosen P, Kaushal S, Wingate N. Effect of cataract surgery on the corneal endothelium: modern phacoemulsification compared with extracapsular cataract surgery. Ophthalmology. 2004 Apr;111(4):679-85. — View Citation
Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11. Review. — View Citation
Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997 Mar;38(3):779-82. — View Citation
Gogate PM, Kulkarni SR, Krishnaiah S, Deshpande RD, Joshi SA, Palimkar A, Deshpande MD. Safety and efficacy of phacoemulsification compared with manual small-incision cataract surgery by a randomized controlled clinical trial: six-week results. Ophthalmology. 2005 May;112(5):869-74. — View Citation
Lundström M, Goh PP, Henry Y, Salowi MA, Barry P, Manning S, Rosen P, Stenevi U. The changing pattern of cataract surgery indications: a 5-year study of 2 cataract surgery databases. Ophthalmology. 2015 Jan;122(1):31-8. doi: 10.1016/j.ophtha.2014.07.047. Epub 2014 Sep 16. — View Citation
Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14. — View Citation
Trnavec B, Cuvala J, Cernák A, Vodrázková E. [Comparison of corneal endothelial cells after ECCE and phacoemulsification of the lens]. Cesk Slov Oftalmol. 1997 Aug;53(4):240-3. Slovak. — View Citation
Wang W, Yan W, Müller A, He M. A Global View on Output and Outcomes of Cataract Surgery With National Indices of Socioeconomic Development. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3669-3676. doi: 10.1167/iovs.17-21489. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of endothelial cell loss | specular microscopy will be done to measure the endothelial cell count before and after the intervention to measure the percentage of loss | 5 minutes | |
Secondary | changes in shape of endothelial cell | specular microscopy will be done to identify changes in hexagonality of endothelial cells after the intervention | 5 minutes |
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