Diabetes MellitusNCT00446277
Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
An observational study of Diabetes Mellitus, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
The aim of the present study is to evaluate changes in the morphology and function of the corneal endothelium before and after cataract surgery in patients with diabetes type II. Also to explain if determination of HgbA1c in diabetics is a predictor for the changes in morphology and function. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Jun 2007
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cataract scheduled for surgery
Who cannot join
- Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Frederiksberg University Hospital
Frederiksberg, Copenhagen, 2000
About this study
The aim of the present study is to evaluate changes in the morphology and function of the corneal endothelium before and after cataract surgery in patients with diabetes type II. Also to explain if determination of HgbA1c in diabetics is a predictor for the changes in morphology and function.
Read the detailed description
Thirty patients with Diabetes type II and thirty non-diabetes patients scheduled to cataract surgery (phacoemulsification with intraocular lens implantation) were invited to participate in the study. Preoperatively, all patients had a full eye examination and 3 endothelial cell photos were taken.
Three months postoperatively the patients were called for a re-examination including 3 endothelial cell photos. The function of the cornea is dependent of the number and morphology of the endothelial cells, and even small traumas like cataract surgery may disrupt the cornea integrity leading to corneal haze and blur. Diabetics may be more vulnerable to corneal stress.
- Conditions
- Diabetes Mellitus
- Being tested
- cataract surgery
- Keywords
- cataract surgery, endothelial cell, cell loss, diabetes, mellitus type II
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal endothelial cell count (cells / mm2)
percentage of hexagonal cells
variation in cell size
central corneal thickness
Secondary outcomes (2)
visual acuity
intraocular pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2007 (estimated)
- Study completionJun 2007 (estimated)
Why it stopped: The present study was joining 2005-41-4933 into one study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Allan Storr-Paulsen, MD, Principal investigator, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446277
- Sponsor's protocol ID
- ASP01
- Status last verified
- May 2008
- First submitted
- 9 Mar 2007
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Cell Loss in Diabetes Type II During Cataract Surgery
- ClinicalTrials.gov ID
- NCT00446277
- Acronym / sponsor ID
- ASP01
- Conditions
- Diabetes Mellitus
- Keywords
- cataract surgery, endothelial cell, cell loss, diabetes, mellitus type II
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: The present study was joining 2005-41-4933 into one study
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2007 (estimated)
- Study completion
- Jun 2007 (estimated)
- First posted
- 12 Mar 2007 (estimated)
- 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.
The aim of the present study is to evaluate changes in the morphology and function of the corneal endothelium before and after cataract surgery in patients with diabetes type II. Also to explain if determination of HgbA1c in diabetics is a predictor for the changes in morphology and function.
Detailed description
Thirty patients with Diabetes type II and thirty non-diabetes patients scheduled to cataract surgery (phacoemulsification with intraocular lens implantation) were invited to participate in the study. Preoperatively, all patients had a full eye examination and 3 endothelial cell photos were taken.
Three months postoperatively the patients were called for a re-examination including 3 endothelial cell photos. The function of the cornea is dependent of the number and morphology of the endothelial cells, and even small traumas like cataract surgery may disrupt the cornea integrity leading to corneal haze and blur. Diabetics may be more vulnerable to corneal stress.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cataract scheduled for surgery
Key exclusion criteria (1 listed)
- Patients with corneal diseases, glaucoma or uveitis, previous intraocular surgery or eye traumas.
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 |
|---|---|---|
| cataract surgery | Procedure or surgery | – |
Primary outcome
corneal endothelial cell count (cells / mm2)
percentage of hexagonal cells
variation in cell size
central corneal thickness
2 secondary outcomes
visual acuity
intraocular pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Allan Storr-Paulsen, MD principal investigator
Frederiksberg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Frederiksberg University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: paused, as of the sponsor's last update on 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
corneal endothelial cell count (cells / mm2). The study lists 4 primary outcomes in all. 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 12 May 2008.