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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Cataract
• Intervention / Treatment: Other: specular microscope

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 Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 86 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Among the 60 patients enrolled in this study, the experimental group was 77.5 ±9.2 years old, and the control age was 76.3±8.7 years, with no statistical difference (P = 0.87). All patients were treated for 3 months.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the diabetic group; patients with type 2 diabetes scheduled to undergo cataract surgery	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.
the control group; patients without diabetes scheduled to undergo cataract surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): June 30, 2016
• Study Completion (ACTUAL): July 30, 2016

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (ACTUAL): August 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: phacoemulsification; type 2 diabetes mellitus; cataract; corneal endothelial cells
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Lens Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Cataract
• Other Study ID Numbers: 17102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No