Cataract SenileNCT04140383
Cataract Surgery In Patients With Advanced Age
An observational study of Cataract Senile, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates and compares clinical outcomes of < 85 and ≥ 85 year old patients who underwent cataract surgeries. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Cataract Surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2017to 25 Feb 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: patients aged 65 years and older who underwent cataract surgery
Who may be able to join
- patients aged 65 years and older patients who underwent cataract surgery
Who cannot join
- patients aged below 65 years who underwent cataract surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Ophthalmology Department
Sakarya
About this study
Official title: Outcomes of Cataract Surgeries in Patients With Advanced Age
This study evaluates and compares clinical outcomes of < 85 and ≥ 85 year old patients who underwent cataract surgeries.
Read the detailed description
The medical records of patients who were underwent cataract surgery between January 2014 and October 2017 were investigated retrospectively and patients 65 years and older were recruited. Two groups were made according to age: group1 composed of patients age range between 65 and 85 years and group 2 composed of patients 85 years and older. Gender, presence of diabetes mellitus (DM), hypertension (HT), drug use were noted.
The results of best corrected visual acuity (BCVA) converted to LogMar, intraocular pressure (IOP) before and 3 months after operation, biomicroscopic and fundus examinations were investigated.
Additional ocular diseases such as glaucoma, age related macular degeneration (AMD), pseudoexfoliation syndrome, retinopathies and maculopathies related to systemic diseases were noted. Pupil dilation properties were also noted as poor, mid or full pupil dilation.
Cataract surgery techniques such as phacoemulsification, extra- and intracapsular lens extractions, peroperative complications, intracameral drug use were investigated.
these aforementioned outcomes evaluated and compared between groups.
- Conditions
- Cataract Senile
- Being tested
- Cataract Surgery
- Keywords
- geriatry, cataract surgery, advanced age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract SurgeryProcedure or surgery
Cataract surgery was performed by using phacoemulsification technique, routinely. But other techniques for instance extra or intracapsular cataract extraction (ECCE, ICCE) techniques were performed when needed. Phacoemulsification technique was performed by 2 experienced surgeon (G.A. and E.C.) under topical anesthesia, thorough limbal incision. Foldable single piece hydrophobic acrylic intraocular lens (IOL) was inserted in the bag. In the presence of complications related to anterior or posterior capsules, 3 pieces IOL was preferred. When ECCE technique was chosen, single piece polymethyl methacrylate IOL was inserted.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, patients aged 85 years and older | 75 eyes of 75 patients (39 female, 36 male) Mean age: 86,8 ± 1,8 years Receives: Procedure: Cataract Surgery | |
| Group 2, patients aged 65 and 85 years | 77 eyes of 77 patients (34 female, 43 male) Mean age:73,3 ± 5,2 years Receives: Procedure: Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Best corrected visual acuity converted to LogMar
Measured: Before cataract surgery
Best corrected visual acuity
Best corrected visual acuity converted to LogMar
Measured: three months after cataract surgery
Secondary outcomes (15)
presence of Diabetes Mellitus
number of participants who have diabetes mellitus
Measured: Baseline (Before cataract surgery)
presence of essential hypertension
number of participants who have essential hypertension
Measured: before cataract surgery
oral acetylsalicylic acid use
number of participants who have a history of acetylsalicylic acid use
Measured: before cataract surgery
oral flomax use
number of participants who have a history of oral flomax use
Measured: before cataract surgery
presence of age related macular degeneration
number of participants who have age related macular degeneration
Measured: Baseline (Before cataract surgery)
presence of glaucoma
number of participants who have glaucoma
Measured: before cataract surgery
presence of pseudoexfoliation
number of participants who have pseudoexfoliation
Measured: before cataract surgery
presence of poor pupil dilation
number of participants who have poor pupil dilation
Measured: During cataract surgery
presence of zonule deficiency
number of participants who have zonule deficiency
Measured: During cataract surgery
Cataract types in patients who underwent cataract surgery
number of participants who have nuclear, posterior subcapsular, corticonuclear, mature, nigra, traumatic cataract
Measured: Baseline (Before cataract surgery)
measurement of effective phacoemulsification time
measurement of effective phacoemulsification time in participants who underwent cataract surgery
Measured: During cataract surgery
presence of posterior capsule rupture
participants who had posterior capsule rupture during surgery
Measured: During cataract surgery
anterior vitrectomy
number of participants who needed anterior vitrectomy during cataract surgery
Measured: during surgery
presence of aphakia
number of participants who left aphakic after cataract surgery
Measured: 3 months after cataract surgery
intracameral adrenalin use
number of participants who needed intracameral adrenalin use
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start2 Oct 2017
- Primary completion2 Dec 2017
- Study completion25 Feb 2018
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 Cataract SenileStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Çakır, Sakarya University
- Investigators
- Burcin Cakir, MD, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140383
- Sponsor's protocol ID
- Sakarya Ophthalmology
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Syam PP, Eleftheriadis H, Casswell AG, Brittain GP, McLeod BK, Liu CS. Clinical outcome following cataract surgery in very elderly patients. Eye (Lond). 2004 Jan;18(1):59-62. doi: 10.1038/sj.eye.6700521.
PubMed 14707968
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Cataract Surgeries in Patients With Advanced Age
- ClinicalTrials.gov ID
- NCT04140383
- Acronym / sponsor ID
- Sakarya Ophthalmology
- Conditions
- Cataract Senile
- Keywords
- geriatry, cataract surgery, advanced age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 2 Dec 2017 (actual)
- Study completion
- 25 Feb 2018 (actual)
- First posted
- 25 Oct 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.
This study evaluates and compares clinical outcomes of < 85 and ≥ 85 year old patients who underwent cataract surgeries.
Detailed description
The medical records of patients who were underwent cataract surgery between January 2014 and October 2017 were investigated retrospectively and patients 65 years and older were recruited. Two groups were made according to age: group1 composed of patients age range between 65 and 85 years and group 2 composed of patients 85 years and older. Gender, presence of diabetes mellitus (DM), hypertension (HT), drug use were noted.
The results of best corrected visual acuity (BCVA) converted to LogMar, intraocular pressure (IOP) before and 3 months after operation, biomicroscopic and fundus examinations were investigated.
Additional ocular diseases such as glaucoma, age related macular degeneration (AMD), pseudoexfoliation syndrome, retinopathies and maculopathies related to systemic diseases were noted. Pupil dilation properties were also noted as poor, mid or full pupil dilation.
Cataract surgery techniques such as phacoemulsification, extra- and intracapsular lens extractions, peroperative complications, intracameral drug use were investigated.
these aforementioned outcomes evaluated and compared between groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, patients aged 85 years and older | – | Procedure: Cataract Surgery75 eyes of 75 patients (39 female, 36 male) Mean age: 86,8 ± 1,8 years |
| Group 2, patients aged 65 and 85 years | – | Procedure: Cataract Surgery77 eyes of 77 patients (34 female, 43 male) Mean age:73,3 ± 5,2 years |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients aged 65 years and older who underwent cataract surgery
Key inclusion criteria (1 listed)
- patients aged 65 years and older patients who underwent cataract surgery
Key exclusion criteria (1 listed)
- patients aged below 65 years who underwent cataract surgery
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 |
|---|---|---|
| Cataract SurgeryCataract surgery was performed by using phacoemulsification technique, routinely. But other techniques for instance extra or intracapsular cataract extraction (ECCE, ICCE) techniques were performed when needed. Phacoemulsification technique was performed by 2 experienced surgeon (G.A. and E.C.) under topical anesthesia, thorough limbal incision. Foldable single piece hydrophobic acrylic intraocular lens (IOL) was inserted in the bag. In the presence of complications related to anterior or posterior capsules, 3 pieces IOL was preferred. When ECCE technique was chosen, single piece polymethyl methacrylate IOL was inserted. | Procedure or surgery | Group 1, patients aged 85 years and older, Group 2, patients aged 65 and 85 years |
Primary outcome
Best corrected visual acuity
Time frame: Before cataract surgery
Best corrected visual acuity converted to LogMar
Best corrected visual acuity
Time frame: three months after cataract surgery
Best corrected visual acuity converted to LogMar
15 secondary outcomes
presence of Diabetes Mellitus
Time frame: Baseline (Before cataract surgery)
presence of essential hypertension
Time frame: before cataract surgery
oral acetylsalicylic acid use
Time frame: before cataract surgery
oral flomax use
Time frame: before cataract surgery
presence of age related macular degeneration
Time frame: Baseline (Before cataract surgery)
presence of glaucoma
Time frame: before cataract surgery
presence of pseudoexfoliation
Time frame: before cataract surgery
presence of poor pupil dilation
Time frame: During cataract surgery
presence of zonule deficiency
Time frame: During cataract surgery
Cataract types in patients who underwent cataract surgery
Time frame: Baseline (Before cataract surgery)
measurement of effective phacoemulsification time
Time frame: During cataract surgery
presence of posterior capsule rupture
Time frame: During cataract surgery
anterior vitrectomy
Time frame: during surgery
presence of aphakia
Time frame: 3 months after cataract surgery
intracameral adrenalin use
Time frame: during surgery
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 25 Oct 2019.
- Results publication: PubMed 14707968Syam PP, Eleftheriadis H, Casswell AG, Brittain GP, McLeod BK, Liu CS. Clinical outcome following cataract surgery in very elderly patients. Eye (Lond). 2004 Jan;18(1):59-62. doi: 10.1038/sj.eye.6700521.
- Sussex Eye Hospital, Brighton, United KingdomLink provided by the sponsor.
- 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.
Burcin Cakir, MD principal investigator
Sakarya 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 Cataract Senile, run by Sakarya University 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 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 25 Oct 2019. 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?
Best corrected visual acuity (time frame: Before cataract surgery). 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?
On the ClinicalTrials.gov record for NCT04140383, 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 25 Oct 2019.