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NCT Number: NCT03260673

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.

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Key information

Conditions

Cataract Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Lens Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

58 year–86 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

the experimental group:

  • Clinical diagnosis of cataract
  • Type 2 diabetes mellitus
  • The recent blood glucose control was stable
  • The glycosylated hemoglobin < 8%

The control group:

  • Clinical diagnosis of cataract
  • No history of type 2 diabetes

Exclusion criteria

  • Corneal lesions
  • Anterior inflammation
  • Ocular trauma or surgical history
  • Glaucoma
  • Corneal endothelial cell density < 1500 / mm squared

Treatment and study plan

specular microscope

Other

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.

Primary outcomes

  1. Comparison of the corneal endothelial cell density before-after cataract surgery

    Time frame: 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 outcomes

  1. Comparison of the endothelial cell size before-after cataract surgery

    Time frame: half year

    Comparison of the endothelial cell size before-after cataract surgery，the size is measured in square microns.

  2. Comparison of the percentage of hexagonal cells before-after cataract surgery

    Time frame: half year

    Comparison of the percentage of hexagonal cells before-after cataract surgery,the percentage are expressed as "%".

  3. Comparison of the central corneal thickness(CCT) before-after cataract surgery

    Time frame: half year

    Comparison of the central corneal thickness(CCT) before-after cataract surgery，the thickness is in microns.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 24, 2017
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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