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

Completed

• Conditions: Diabetes Mellitus; Cataract
• Interventions: Other: specular microscope

• Registration Number: NCT03260673
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-06-30
• Study Completion: 2016-07-30
• Study First Submitted: 2017-07-27
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-21
• Last Update Submitted: 2017-08-21
• Study First Posted: 2017-08-24
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the diabetic group	specular microscope	patients with type 2 diabetes scheduled to undergo cataract surgery
the control group	specular microscope	patients without diabetes scheduled to undergo cataract surgery

Primary Outcome Measures

Name	Time	Method
Comparison of the corneal endothelial cell density before-after cataract surgery	half year	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of the endothelial cell size before-after cataract surgery	half year	Comparison of the endothelial cell size before-after cataract surgery，the size is measured in square microns.
Comparison of the percentage of hexagonal cells before-after cataract surgery	half year	Comparison of the percentage of hexagonal cells before-after cataract surgery,the percentage are expressed as "%".
Comparison of the central corneal thickness(CCT) before-after cataract surgery	half year	Comparison of the central corneal thickness(CCT) before-after cataract surgery，the thickness is in microns.