CataractECOCHINCT03972670
Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery
An observational study of Cataract and Phacoemulsification, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
To study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Phacoemulsification
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 1 Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing surgery were older than 18 years. Subjects had cataract up to C5, N4 and P5 on the LOCS III classification
Who may be able to join
- The presence of senile cataract with equivalent grades and a history of visual acuity regression
Who cannot join
- Patient with total white cataract
- With history of ocular surgery
- With other eye diseases (corneal pathology, Fuchs dystrophy, uveitis and glaucoma) or systemic diseases (diabetic disorder and dementia)
About this study
Official title: Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery by Phacoemulsification
To study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification.
Read the detailed description
Cataract surgery facilitates improved visual acuity through extraction of an opacified lens, followed by intraocular lens implantation. An average adult cornea has 2000 to 2500 cells/mm2, a count that diminishes with age with a rate of attrition of approximately 0.3% to 0.5% per year. Long-term postoperative corneal transparency depends on the morphological stability and functional integrity of the corneal endothelium. It is well established that all surgical interventions that require entry into the anterior chamber result in some damage to the corneal endothelium.
Endothelial cell loss results in cell hypertrophy to maintain continuity, resulting in a change in endothelium cell density and morphology. Many studies have assessed the impact of various surgical techniques on endothelial damage and numerous studies have investigated the factors influencing endothelial cell loss after phacoemulsification. The goal of this study is to investigate the correlation of postoperative corneal edema with the reduction of endothelial corneal cell density after phacoemulsification.
- Conditions
- Cataract, Phacoemulsification
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Pachymetry
Measurement of the thickness of the eye's cornea with a pachymeter
Measured: Day 1
Secondary outcomes (3)
Endothelial cell density
Endothelial cell density measurements with noncontact specular microscope
Measured: Day 1
Pachymetry after 1 month
Measurement of the thickness of the eye's cornea with a pachymeter
Measured: Day 30
Endothelial cell density after 1 month
Endothelial cell density measurements with noncontact specular microscope
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Aug 2014
- Primary completion30 Nov 2014
- Study completion1 Jan 2018
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972670
- Sponsor's protocol ID
- 2018-13Obs-CHRMT
- Acronym
- ECOCHI
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Postoperative Central Corneal Thickness and Endothelial Damage After Cataract Surgery by Phacoemulsification
- ClinicalTrials.gov ID
- NCT03972670
- Acronym / sponsor ID
- ECOCHI / 2018-13Obs-CHRMT
- Conditions
- Cataract, Phacoemulsification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 4 Jun 2019 (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.
To study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification.
Detailed description
Cataract surgery facilitates improved visual acuity through extraction of an opacified lens, followed by intraocular lens implantation. An average adult cornea has 2000 to 2500 cells/mm2, a count that diminishes with age with a rate of attrition of approximately 0.3% to 0.5% per year. Long-term postoperative corneal transparency depends on the morphological stability and functional integrity of the corneal endothelium. It is well established that all surgical interventions that require entry into the anterior chamber result in some damage to the corneal endothelium.
Endothelial cell loss results in cell hypertrophy to maintain continuity, resulting in a change in endothelium cell density and morphology. Many studies have assessed the impact of various surgical techniques on endothelial damage and numerous studies have investigated the factors influencing endothelial cell loss after phacoemulsification. The goal of this study is to investigate the correlation of postoperative corneal edema with the reduction of endothelial corneal cell density after phacoemulsification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery were older than 18 years. Subjects had cataract up to C5, N4 and P5 on the LOCS III classification
Key inclusion criteria (1 listed)
- The presence of senile cataract with equivalent grades and a history of visual acuity regression
Key exclusion criteria (3 listed)
- Patient with total white cataract
- With history of ocular surgery
- With other eye diseases (corneal pathology, Fuchs dystrophy, uveitis and glaucoma) or systemic diseases (diabetic disorder and dementia)
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
Pachymetry
Time frame: Day 1
Measurement of the thickness of the eye's cornea with a pachymeter
3 secondary outcomes
Endothelial cell density
Time frame: Day 1
Pachymetry after 1 month
Time frame: Day 30
Endothelial cell density after 1 month
Time frame: Day 30
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 4 Jun 2019.
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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 Phacoemulsification, run by Centre Hospitalier Régional Metz-Thionville.
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 4 Jun 2019. 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?
Pachymetry (time frame: Day 1). 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 4 Jun 2019.