Postoperative Neurocognitive DisordersNCT07423416
Validation of the Modified Cognitive Assessment Scale (MoCA Blind) for the Diagnosis of Postoperative Neurocognitive Disorders in Patients With Corneal Pathology in Russia.
An observational study of Postoperative Neurocognitive Disorders, run by The S.N. Fyodorov Eye Microsurgery State Institution.
Trial summary
Long-term observation has shown that patients with visual impairment often develop cognitive impairments. Due to the fact that patients who are planning to undergo corneal transplantation may have initial cognitive deficits, assessing cognitive function is an important aspect of work for both the anesthesiologist and… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Neurocognitive Disorders
- What is being tested?
- Neurocognitive testing
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Russian-speaking patients with corneal pathology who are planning a corneal transplant in the future
Who may be able to join
- patients with corneal pathology, including burns, ulcers, dystrophies, and keratoectasia, as well as those with a history of corneal injuries
- physical status of I-III on the ASA scale.
Who cannot join
- children
- patients with sensorineural hearing loss
- patients with chronic cerebrovascular disorders
- patients with initially high levels of anxiety and depressive symptoms
- patients with severe cognitive impairments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Long-term observation has shown that patients with visual impairment often develop cognitive impairments. Due to the fact that patients who are planning to undergo corneal transplantation may have initial cognitive deficits, assessing cognitive function is an important aspect of work for both the anesthesiologist and the operating surgeon. Given the high significance of assessing cognitive function after anesthesia in ophthalmic surgery patients, it is relevant to adapt and validate the Russian version of the MoCA Blind test for subsequent use in clinical practice.
- Conditions
- Postoperative Neurocognitive Disorders
- Being tested
- Neurocognitive testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive testingDiagnostic test
The psychometric properties of the Russian version of the MoCA Blind scale were evaluated according to the following parameters: reliability (reproducibility and internal consistency), validity (content and construct), and sensitivity.
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative neurocognitive disorders
Postoperative neurocognitive disorders were identified by comparing the results of neuropsychological tests performed before surgery and on the 90th day after surgery. An individual Z-score was used for each domain of the test.
Measured: From the moment of inclusion in the study until the end of treatment 90 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Neurocognitive DisordersStudies 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexander Romanov, The S.N. Fyodorov Eye Microsurgery State Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423416
- Sponsor's protocol ID
- SNF1
- Other IDs
- № 143 01.01.2026
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No final decision has been made.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Modified Cognitive Assessment Scale (MoCA Blind) for the Diagnosis of Postoperative Neurocognitive Disorders in Patients With Corneal Pathology in Russia.
- ClinicalTrials.gov ID
- NCT07423416
- Acronym / sponsor ID
- SNF1
- Conditions
- Postoperative Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State InstitutionOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Feb 2026 (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.
Long-term observation has shown that patients with visual impairment often develop cognitive impairments. Due to the fact that patients who are planning to undergo corneal transplantation may have initial cognitive deficits, assessing cognitive function is an important aspect of work for both the anesthesiologist and the operating surgeon. Given the high significance of assessing cognitive function after anesthesia in ophthalmic surgery patients, it is relevant to adapt and validate the Russian version of the MoCA Blind test for subsequent use in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Russian-speaking patients with corneal pathology who are planning a corneal transplant in the future
Key inclusion criteria (2 listed)
- patients with corneal pathology, including burns, ulcers, dystrophies, and keratoectasia, as well as those with a history of corneal injuries
- physical status of I-III on the ASA scale.
Key exclusion criteria (5 listed)
- children
- patients with sensorineural hearing loss
- patients with chronic cerebrovascular disorders
- patients with initially high levels of anxiety and depressive symptoms
- patients with severe cognitive impairments.
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 |
|---|---|---|
| Neurocognitive testingThe psychometric properties of the Russian version of the MoCA Blind scale were evaluated according to the following parameters: reliability (reproducibility and internal consistency), validity (content and construct), and sensitivity. | Diagnostic test | – |
Primary outcome
postoperative neurocognitive disorders
Time frame: From the moment of inclusion in the study until the end of treatment 90 days later
Postoperative neurocognitive disorders were identified by comparing the results of neuropsychological tests performed before surgery and on the 90th day after surgery. An individual Z-score was used for each domain of the test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided. No final decision has been made.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Neurocognitive Disorders, run by The S.N. Fyodorov Eye Microsurgery State Institution.
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 2 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandr Alexandr Romanov (+79182942721, Saha_ro@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative neurocognitive disorders (time frame: From the moment of inclusion in the study until the end of treatment 90 days later). 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 21 Sep 2026.