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NCT03260673 Clinical Trial

Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:
白内障超声乳化术对2型糖尿病患者角膜内皮细胞的影响 Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03260673
Other study ID # 17102
Secondary ID
Status Completed
Phase N/A
First received July 27, 2017
Last updated August 21, 2017
Start date September 1, 2015
Est. completion date July 30, 2016

Study information
Verified date August 2017
Source Beijing Tsinghua Chang Gung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigate the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

Description:

The investigators do the clinical prospective study including 30 patients with type 2 diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.Then, the investigators compared the two sets of data. At last observing the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 30, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group 58 Years to 86 Years
Eligibility Inclusion Criteria:

the experimental group:

1. Clinical diagnosis of cataract

2. Type 2 diabetes mellitus

3. The recent blood glucose control was stable

4. The glycosylated hemoglobin < 8%

The control group:

1. Clinical diagnosis of cataract

2. No history of type 2 diabetes

Exclusion Criteria:

1. Corneal lesions

2. Anterior inflammation

3. Ocular trauma or surgical history

4. Glaucoma

5. Corneal endothelial cell density < 1500 / mm squared

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• specular microscope
The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Beijing Tsinghua Chang Gung Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of the corneal endothelial cell density before-after cataract surgery Comparison of the corneal endothelial cell density before-after cataract surgery,the density is expressed in terms of the number of cells per square millimeter. half year
Secondary Comparison of the endothelial cell size before-after cataract surgery Comparison of the endothelial cell size before-after cataract surgery,the size is measured in square microns. half year
Secondary Comparison of the percentage of hexagonal cells before-after cataract surgery Comparison of the percentage of hexagonal cells before-after cataract surgery,the percentage are expressed as "%". half year
Secondary Comparison of the central corneal thickness(CCT) before-after cataract surgery Comparison of the central corneal thickness(CCT) before-after cataract surgery,the thickness is in microns. half year
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