CataractNCT06482996
General Anesthesia on Blood Pressure and Intraocular Pressure in Geriatric Patients Undergoing Cataract Surgery
An observational study of Cataract, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of the study is to investigate the correlation between preoperative hemodynamics and frailty scores in patients undergoing cataract surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Intraocular pressure (IOP) was measured
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2023to 27 Feb 2026
- How long will I take part?
- 1 Day
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: This prospective randomized controlled double-blind study included a total of 80 ASA I-III patients aged 65-85 years undergoing cataract surgery under general anesthesia. Randomization Patients were randomly divided into two groups with frailty score as non-frail (40 patients) and pre-frail/frail (40 patients) by closed envelope method.
Who may be able to join
- 65-85 age
- ASA I-III
- cataract surgery with genel anesthesia
Who cannot join
- cerebrovascular disease,
- mental retardation and psychiatric illness,
- pulmonary infection, history of advanced COPD or respiratory failure,
- EF less than 40%, presence of cardiovascular disease,
- bleeding diathesis,
- renal and hepatic insufficiency,
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- presence of diabetes mellitus, diuretic/mannitol users,
- substance abuse
- BMI >30
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and Research hospital
Istanbul, 34764
About this study
Official title: the Impact of General Anesthesia on Blood Pressure and Intraocular Pressure in Geriatric Patients Undergoing Cataract Surgery
The primary aim of the study is to investigate the correlation between preoperative hemodynamics and frailty scores in patients undergoing cataract surgery under general anesthesia. The secondary objective is to explore the relationship between preoperative and postoperative intraocular pressure changes and frailty scores.
Read the detailed description
Cataract stands as a significant cause of vision impairment worldwide, notably prevalent among the elderly. This study aims to explore the changes in intraocular pressure (IOP) and blood pressure under general anesthesia during cataract surgery in frail geriatric patients. The research emphasizes the critical role of frailty assessment in determining surgical risks among elderly surgical patients. It focuses on the hypothesis that frail individuals undergoing cataract surgery under general anesthesia might experience more pronounced effects on IOP and blood pressure during the surgical procedure compared to prefrail counterparts. This study emerges as a crucial step in understanding the impact of preoperative frailty assessment on surgical planning and outcomes.
- Conditions
- Cataract
- Being tested
- Intraocular pressure (IOP) was measured
- Keywords
- Cataract surgery, Frailty
- Medical subject headings
- Cataract, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure (IOP) was measuredOther
The Frail Scale was used to assess the frailty of the patients.Intraocular pressure (IOP) was measured before anesthesia, 5 minutes after induction of anesthesia and 1 hour postoperatively. IOP was measured using a Tono-pen tonometer (AccuPen). The normal range of IOP is 11-21 mmHg (mean 16 mmHg) and values above 24 mmHg are pathologic.
| Study group | Role | What they receive |
|---|---|---|
| group A | Frail scale:Non frail Receives: Other: Intraocular pressure (IOP) was measured | |
| group B | Frail scale: Pre frail/frail Receives: Other: Intraocular pressure (IOP) was measured |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure during genel anesthesia
intraocular pressure (mmHg)
Measured: through study completion, an average of 1 day
Secondary outcomes (1)
hemodynamic data
mean arterial pressure (mmHg)
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start20 Oct 2023
- Primary completion30 Jan 2026
- Study completion27 Feb 2026
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
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482996
- Sponsor's protocol ID
- UERH-AR-ZT-08
- Status last verified
- Oct 2026
- First submitted
- 6 May 2024
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Impact of General Anesthesia on Blood Pressure and Intraocular Pressure in Geriatric Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT06482996
- Acronym / sponsor ID
- UERH-AR-ZT-08
- Conditions
- Cataract
- Keywords
- Cataract surgery, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 1 Jul 2024 (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.
The primary aim of the study is to investigate the correlation between preoperative hemodynamics and frailty scores in patients undergoing cataract surgery under general anesthesia. The secondary objective is to explore the relationship between preoperative and postoperative intraocular pressure changes and frailty scores.
Detailed description
Cataract stands as a significant cause of vision impairment worldwide, notably prevalent among the elderly. This study aims to explore the changes in intraocular pressure (IOP) and blood pressure under general anesthesia during cataract surgery in frail geriatric patients. The research emphasizes the critical role of frailty assessment in determining surgical risks among elderly surgical patients. It focuses on the hypothesis that frail individuals undergoing cataract surgery under general anesthesia might experience more pronounced effects on IOP and blood pressure during the surgical procedure compared to prefrail counterparts. This study emerges as a crucial step in understanding the impact of preoperative frailty assessment on surgical planning and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Other: Intraocular pressure (IOP) was measuredFrail scale:Non frail |
| group B | – | Other: Intraocular pressure (IOP) was measuredFrail scale: Pre frail/frail |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This prospective randomized controlled double-blind study included a total of 80 ASA I-III patients aged 65-85 years undergoing cataract surgery under general anesthesia. Randomization Patients were randomly divided into two groups with frailty score as non-frail (40 patients) and pre-frail/frail (40 patients) by closed envelope method.
Key inclusion criteria (3 listed)
- 65-85 age
- ASA I-III
- cataract surgery with genel anesthesia
Key exclusion criteria (9 listed)
- cerebrovascular disease,
- mental retardation and psychiatric illness,
- pulmonary infection, history of advanced COPD or respiratory failure,
- EF less than 40%, presence of cardiovascular disease,
- bleeding diathesis,
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 |
|---|---|---|
| Intraocular pressure (IOP) was measuredThe Frail Scale was used to assess the frailty of the patients.Intraocular pressure (IOP) was measured before anesthesia, 5 minutes after induction of anesthesia and 1 hour postoperatively. IOP was measured using a Tono-pen tonometer (AccuPen). The normal range of IOP is 11-21 mmHg (mean 16 mmHg) and values above 24 mmHg are pathologic. | Other | group A, group B |
Primary outcome
intraocular pressure during genel anesthesia
Time frame: through study completion, an average of 1 day
intraocular pressure (mmHg)
1 secondary outcome
hemodynamic data
Time frame: through study completion, an average of 1 day
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 9 Oct 2026.
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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.
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 Cataract, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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 9 Oct 2026. 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 Turkey (Türkiye). 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?
intraocular pressure during genel anesthesia (time frame: through study completion, an average of 1 day). 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 9 Oct 2026.