CataractNCT03260673
Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus
An observational study of Cataract and Diabetes Mellitus, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
This study investigate the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 58 to 86 years
- Conditions the study is for
- Cataract, Diabetes Mellitus
- What is being tested?
- specular microscope
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 30 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 58 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Corneal lesions
- Anterior inflammation
- Ocular trauma or surgical history
- Glaucoma
- Corneal endothelial cell density < 1500 / mm squared
About this study
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
This study investigate the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.
Read the 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.
- Conditions
- Cataract, Diabetes Mellitus
- Being tested
- specular microscope
- Keywords
- cataract, phacoemulsification, type 2 diabetes mellitus, corneal endothelial cells
- Medical subject headings
- Cataract, Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specular microscopeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| the diabetic group | patients with type 2 diabetes scheduled to undergo cataract surgery Receives: Other: specular microscope | |
| the control group | patients without diabetes scheduled to undergo cataract surgery Receives: Other: specular microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: half year
Secondary outcomes (3)
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.
Measured: 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 "%".
Measured: 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.
Measured: half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Sep 2015
- Primary completion30 Jun 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260673
- Sponsor's protocol ID
- 17102
- Status last verified
- Aug 2017
- First submitted
- 27 Jul 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03260673
- Acronym / sponsor ID
- 17102
- Conditions
- Cataract, Diabetes Mellitus
- Keywords
- cataract, phacoemulsification, type 2 diabetes mellitus, corneal endothelial cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the diabetic group | – | Other: specular microscopepatients with type 2 diabetes scheduled to undergo cataract surgery |
| the control group | – | Other: specular microscopepatients without diabetes scheduled to undergo cataract surgery |
Who may qualify
- Ages
- 58 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Clinical diagnosis of cataract
- Type 2 diabetes mellitus
- The recent blood glucose control was stable
- The glycosylated hemoglobin < 8%
- Clinical diagnosis of cataract
Key exclusion criteria (5 listed)
- Corneal lesions
- Anterior inflammation
- Ocular trauma or surgical history
- Glaucoma
- Corneal endothelial cell density < 1500 / mm squared
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| specular microscopeThe 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. | Other | the control group, the diabetic group |
Primary outcome
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.
3 secondary outcomes
Comparison of the endothelial cell size before-after cataract surgery
Time frame: half year
Comparison of the percentage of hexagonal cells before-after cataract surgery
Time frame: half year
Comparison of the central corneal thickness(CCT) before-after cataract surgery
Time frame: half year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Diabetes Mellitus, run by Beijing Tsinghua Chang Gung Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the corneal endothelial cell density before-after cataract surgery (time frame: half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.