Clinical trial NCT03262285: Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction
Official title: Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction in Management of Senile Cataract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Senile Cataract
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with senile cataract

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of endothelial cell loss
timeFrame: 5 minutes
Secondary outcomes:
measure: changes in shape of endothelial cell
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Ali Ryad, professor
role: STUDY_CHAIR
References:
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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. doi: 10.1016/j.ophtha.2004.11.055.
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citation: 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. doi: 10.1016/j.ophtha.2003.07.015.
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