CataractNCT02698943
Glistenings and PCO Evaluation for the Envista MX60
An observational study of Cataract, run by Democritus University of Thrace.
Trial summary
Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Phacoemulsification
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Feb 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with senile cataract
Who may be able to join
- Diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
Who cannot join
- Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases
About this study
Official title: Evaluation of Glistenings and Posterior Capsule Opacification Following Envista MX60 Intraocular Lens Implantation
Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who underwent phacoemulsification at least 1 year prior to their enrollment at the study
- Conditions
- Cataract
- Being tested
- Phacoemulsification
- Keywords
- cataract; intraocular lens; posterior capsule opacification; glistening; ENVISTA
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
Phacoemulsification for cataract extraction with Envista MX-60 implantation
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Participants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glistenings
Evaluation of glistenings using Scheimpflug analysis
Measured: 1 year
Posterior capsule Opacification (PCO)
Evaluation of PCO using EPCO software
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study chair, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698943
- Sponsor's protocol ID
- 320/2-3-2016
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glistenings and Posterior Capsule Opacification Following Envista MX60 Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT02698943
- Acronym / sponsor ID
- 320/2-3-2016
- Conditions
- Cataract
- Keywords
- cataract; intraocular lens; posterior capsule opacification; glistening; ENVISTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Mar 2016 (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.
Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who underwent phacoemulsification at least 1 year prior to their enrollment at the study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: PhacoemulsificationParticipants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with senile cataract
Key inclusion criteria (1 listed)
- Diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
Key exclusion criteria (1 listed)
- Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases
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 |
|---|---|---|
| PhacoemulsificationPhacoemulsification for cataract extraction with Envista MX-60 implantation | Procedure or surgery | Study Group |
Primary outcome
Glistenings
Time frame: 1 year
Evaluation of glistenings using Scheimpflug analysis
Posterior capsule Opacification (PCO)
Time frame: 1 year
Evaluation of PCO using EPCO software
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 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Georgios Labiris, MD, PhD study chair
Assistant Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Democritus University of Thrace.
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: finished, as of the sponsor's last update on 4 Mar 2016. 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?
Glistenings (time frame: 1 year). The study lists 2 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 4 Mar 2016.