GlaucomaNCT00863018
Corneal Endothelium After Glaucoma Surgery
An observational study of Glaucoma and Corneal Damage, run by Chungnam National University at 1 site in South Korea.
Trial summary
The purpose of this trial is to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma, Corneal Damage, Intraocular Pressure
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2003to Jan 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery
Who may be able to join
- Patients who need glaucoma surgery for intraocular pressure control
Who cannot join
- congenital glaucoma
- Pre-existing corneal abnormality
- lost from follow up without any ocular problem within 6 months from surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery
The purpose of this trial is to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area will be analyzed and compared to the baseline and between the types of the surgeries.
Read the detailed description
To study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Specular microscopy using non-contact type specular microscope (Noncon Robo SP-8000, Konan Medical Inc., Tokyo, Japan) was performed by one experienced examiner before surgery and 1, 6, 12, 18, and 24 months after surgery. All examinations were done at the center, superior, superonasal, and superotemporal area of the cornea, while the patient maintain fixation at the target in the equipment. The follow-up was stopped if serious complication requiring surgical treatment was developed or additional intraocular pressure lowering surgery is needed, and the data before the second surgery were collected.
- Conditions
- Glaucoma, Corneal Damage, Intraocular Pressure
- Keywords
- Corneal endothelial cell, Specular microscopy, Glaucoma implant surgery, Ahmed glaucoma valve, Trabeculectomy
- Medical subject headings
- Glaucoma, Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Eyes with glaucoma and on anti-glaucoma medication but without glaucoma surgery | |
| Implant surgery | Eyes underwent Ahmed glaucoma valve implantation | |
| Trabeculectomy | Eyes underwent conventional trabeculectomy with mitomycin-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area
Measured: 1 and 2 years longitudinal follow up
Secondary outcomes (1)
Clinical factors associated with the damage of corneal endothelium after glaucoma surgery
Measured: 1 and 2 years longitudinal follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startAug 2003
- Primary completionAug 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-sik Kim, Chungnam National University
- Investigators
- Young-ha Lee, MD, PhD, Study director, Research Institute for Medical Science, Chungnam National UniversityChang-sik Kim, MD, PhD, Principal investigator, Ophthalmology, College of Medicine, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863018
- Sponsor's protocol ID
- CNUMC-09-04
- Status last verified
- Jul 2015
- First submitted
- 16 Mar 2009
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee EK, Yun YJ, Lee JE, Yim JH, Kim CS. Changes in corneal endothelial cells after Ahmed glaucoma valve implantation: 2-year follow-up. Am J Ophthalmol. 2009 Sep;148(3):361-7. doi: 10.1016/j.ajo.2009.04.016. Epub 2009 Jun 7.
PubMed 19505676
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery
- ClinicalTrials.gov ID
- NCT00863018
- Acronym / sponsor ID
- CNUMC-09-04
- Conditions
- Glaucoma, Corneal Damage, Intraocular Pressure
- Keywords
- Corneal endothelial cell, Specular microscopy, Glaucoma implant surgery, Ahmed glaucoma valve, Trabeculectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Chungnam National UniversityUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Mar 2009 (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 purpose of this trial is to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area will be analyzed and compared to the baseline and between the types of the surgeries.
Detailed description
To study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Specular microscopy using non-contact type specular microscope (Noncon Robo SP-8000, Konan Medical Inc., Tokyo, Japan) was performed by one experienced examiner before surgery and 1, 6, 12, 18, and 24 months after surgery. All examinations were done at the center, superior, superonasal, and superotemporal area of the cornea, while the patient maintain fixation at the target in the equipment. The follow-up was stopped if serious complication requiring surgical treatment was developed or additional intraocular pressure lowering surgery is needed, and the data before the second surgery were collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Eyes with glaucoma and on anti-glaucoma medication but without glaucoma surgery |
| Implant surgery | – | –Eyes underwent Ahmed glaucoma valve implantation |
| Trabeculectomy | – | –Eyes underwent conventional trabeculectomy with mitomycin-C |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery
Key inclusion criteria (1 listed)
- Patients who need glaucoma surgery for intraocular pressure control
Key exclusion criteria (3 listed)
- congenital glaucoma
- Pre-existing corneal abnormality
- lost from follow up without any ocular problem within 6 months from surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area
Time frame: 1 and 2 years longitudinal follow up
1 secondary outcome
Clinical factors associated with the damage of corneal endothelium after glaucoma surgery
Time frame: 1 and 2 years longitudinal follow up
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 29 Jul 2015.
- Derived from this study: PubMed 19505676Lee EK, Yun YJ, Lee JE, Yim JH, Kim CS. Changes in corneal endothelial cells after Ahmed glaucoma valve implantation: 2-year follow-up. Am J Ophthalmol. 2009 Sep;148(3):361-7. doi: 10.1016/j.ajo.2009.04.016. Epub 2009 Jun 7.
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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.
Young-ha Lee, MD, PhD study director
Research Institute for Medical Science, Chungnam National University
Chang-sik Kim, MD, PhD principal investigator
Ophthalmology, College of Medicine, Chungnam National University
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 Glaucoma and Corneal Damage, run by Chungnam National University at 1 site in South Korea.
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 3 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 29 Jul 2015. 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 South Korea. 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?
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?
Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area (time frame: 1 and 2 years longitudinal follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863018, which also lists 1 linked publication.
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 29 Jul 2015.