- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140383
Cataract Surgery In Patients With Advanced Age
Outcomes of Cataract Surgeries in Patients With Advanced Age
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Sakarya, Turkey
- Sakarya University Ophthalmology Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients aged 65 years and older patients who underwent cataract surgery
Exclusion Criteria:
- patients aged below 65 years who underwent cataract surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1, patients aged 85 years and older
75 eyes of 75 patients (39 female, 36 male) Mean age: 86,8 ± 1,8 years
|
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.
|
|
Group 2, patients aged 65 and 85 years
77 eyes of 77 patients (34 female, 43 male) Mean age:73,3 ± 5,2 years
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Best corrected visual acuity
Time Frame: Before cataract surgery
|
Best corrected visual acuity converted to LogMar
|
Before cataract surgery
|
|
Best corrected visual acuity
Time Frame: three months after cataract surgery
|
Best corrected visual acuity converted to LogMar
|
three months after cataract surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
presence of Diabetes Mellitus
Time Frame: Baseline (Before cataract surgery)
|
number of participants who have diabetes mellitus
|
Baseline (Before cataract surgery)
|
|
presence of essential hypertension
Time Frame: before cataract surgery
|
number of participants who have essential hypertension
|
before cataract surgery
|
|
oral acetylsalicylic acid use
Time Frame: before cataract surgery
|
number of participants who have a history of acetylsalicylic acid use
|
before cataract surgery
|
|
oral flomax use
Time Frame: before cataract surgery
|
number of participants who have a history of oral flomax use
|
before cataract surgery
|
|
presence of age related macular degeneration
Time Frame: Baseline (Before cataract surgery)
|
number of participants who have age related macular degeneration
|
Baseline (Before cataract surgery)
|
|
presence of glaucoma
Time Frame: before cataract surgery
|
number of participants who have glaucoma
|
before cataract surgery
|
|
presence of pseudoexfoliation
Time Frame: before cataract surgery
|
number of participants who have pseudoexfoliation
|
before cataract surgery
|
|
presence of poor pupil dilation
Time Frame: During cataract surgery
|
number of participants who have poor pupil dilation
|
During cataract surgery
|
|
presence of zonule deficiency
Time Frame: During cataract surgery
|
number of participants who have zonule deficiency
|
During cataract surgery
|
|
Cataract types in patients who underwent cataract surgery
Time Frame: Baseline (Before cataract surgery)
|
number of participants who have nuclear, posterior subcapsular, corticonuclear, mature, nigra, traumatic cataract
|
Baseline (Before cataract surgery)
|
|
measurement of effective phacoemulsification time
Time Frame: During cataract surgery
|
measurement of effective phacoemulsification time in participants who underwent cataract surgery
|
During cataract surgery
|
|
presence of posterior capsule rupture
Time Frame: During cataract surgery
|
participants who had posterior capsule rupture during surgery
|
During cataract surgery
|
|
anterior vitrectomy
Time Frame: during surgery
|
number of participants who needed anterior vitrectomy during cataract surgery
|
during surgery
|
|
presence of aphakia
Time Frame: 3 months after cataract surgery
|
number of participants who left aphakic after cataract surgery
|
3 months after cataract surgery
|
|
intracameral adrenalin use
Time Frame: during surgery
|
number of participants who needed intracameral adrenalin use
|
during surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Burcin Cakir, MD, Sakarya University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sakarya Ophthalmology
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cataract Senile
-
Carl Zeiss Meditec AGCompleted
-
Carl Zeiss Meditec AGRecruitingCataract SenileSpain, Bulgaria, Czechia, Romania
-
Vienna Institute for Research in Ocular SurgeryRecruiting
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityBeijing Tongren Hospital; Eye & ENT Hospital of Fudan University; The First Affiliated... and other collaboratorsEnrolling by invitation
-
Taipei Nobel Eye ClinicCompletedCataract SenileTaiwan
-
Wendell ScottJohnson & Johnson Surgical Vision, Inc.CompletedCataract SenileUnited States
-
Carl Zeiss Meditec AGCompletedCataract SenileRomania
-
Carl Zeiss Meditec AGCompleted
-
Johannes Kepler University of LinzCompleted
-
Vienna Institute for Research in Ocular SurgeryCompleted
Clinical Trials on Cataract Surgery
-
Zagazig UniversityCompleted
-
Iladevi Cataract and IOL Research CenterCompletedCataract Surgery | Shallow Anterior Chamber | PhacoemulsificationIndia
-
Technolas Perfect Vision GmbHCompletedCataractCzech Republic, India
-
University of OklahomaCompletedPrimary Open Angle Glaucoma | Cataract | Pigmentary GlaucomaUnited States
-
Technolas Perfect Vision GmbHCompletedCataractCzech Republic, India
-
Ziemer Ophthalmic Systems AGCompleted
-
Technolas Perfect Vision GmbHCompleted
-
Medical University of GrazRecruiting
-
Glaukos CorporationCompletedOpen-Angle GlaucomaUnited States
-
Guy's and St Thomas' NHS Foundation TrustCompletedCataract | Surgery