Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction

Senile Cataract Clinical Trial

Official title:

Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction in Management of Senile Cataract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262285
• Other study ID #: CECLPEECCE
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: January 15, 2021

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

the investigators will compare between the endothelial cell loss after phacoemulsification and extracapsular cataract extraction in management of senile cataract

Description:

Age related cataract is believed to be the main cause of reversible blindness worldwide and in developing countries. Population-based studies have reported that cataract is responsible for 47.8% to 51% of all global blindness.

Several studies compared phacoemulsification and conventional extracapsular cataract extraction regarding several aspects such as postoperative inflammation and visual rehabilitation. studies proved that phacoemulsification has faster rehabilitation ,less astigmatism and better postoperative vision .However, Extracapsular cataract extraction is still the operation of choice in some cataract cases.

The normal corneal endothelium is a single layer of uniformly sized cells with a predominantly hexagonal shape. Adult density of approximately 2400 - 3200 cells/mm².The number of cells decreases at about 0.6% per year and neighbouring cells enlarge to fill the space as the cells cannot regenerate.The minimum cell density necessary for adequate function is in the range of 400 to 700 cells/mm2.

The effect of cataract surgery on corneal endothelium is an important factor that affects postoperative vision .However, it is accepted all over the world that there is definite loss of some endothelial cells with all techniques of cataract surgery. Previously, cataract surgery caused enormous loss of endothelial cells , but with enhancement of equipment and surgical techniques, cataract surgery today results in 6-14%loss of endothelial cells.

Specular microscopy is a noninvasive photographic technique that allows visualization and analysis of corneal endothelium. specular microscopy is used to show cell count and cell shape in the scanned area.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Cell Loss
• Senile Cataract

Intervention

Procedure:
• phacoemulsification
removal of cataract using ultrasound waves
• extracapsular cataract extraction
removal of cataract using surgical corneal incision

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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

Outcome

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