- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439809
The Effect of Periodic Intensive Education on Surgical Outcomes in Cataract Surgery Patients
The Effect of Periodic Intensive Education Intervention on Surgical Outcomes in Elderly Patients Undergoing Cataract Surgery
The goal of this clinical trial is to learn whether periodic education can improve recovery outcomes in older adults undergoing cataract surgery. The main questions it aims to answer are:
Does periodic education improve patients' adherence to prescribed eye medications after cataract surgery?
Does periodic education reduce postoperative complications and improve vision-related quality of life?
Researchers will compare patients who receive structured periodic education in addition to routine postoperative care with those who receive routine postoperative care alone to see if education improves recovery outcomes.
Participants will:
Receive either routine postoperative care or structured periodic education about correct eye drop use and self-care practices
Attend follow-up visits during the first three weeks after surgery
Complete questionnaires to assess medication adherence and vision-related quality of life
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detailed Description:
Cataract surgery is one of the most frequently performed surgical procedures among older adults and is generally associated with favorable visual outcomes. However, successful postoperative recovery largely depends on patients' adherence to prescribed eye medications and their ability to perform appropriate self-care practices during the early recovery period. Inadequate medication adherence may lead to preventable complications such as infection, inflammation, or delayed healing, which can negatively affect surgical outcomes and vision-related quality of life.
This randomized controlled trial aims to evaluate the effectiveness of periodic education provided to older adults undergoing cataract surgery on medication adherence, postoperative complication rates, and vision-related quality of life. Eligible participants will be randomly assigned to either a routine care group or a periodic education intervention group.
Participants in the intervention group will receive structured education regarding correct eye drop administration, medication schedule adherence, hygiene practices, and postoperative care recommendations. Educational support will be delivered at predetermined intervals following surgery through face-to-face sessions and follow-up contacts to reinforce adherence behaviors.
Primary and secondary outcomes will be assessed during follow-up visits within the first three weeks after surgery. Medication adherence levels, incidence of postoperative complications, and changes in vision-related quality of life will be evaluated using validated assessment tools.
The results of this study are expected to provide evidence on the effectiveness of structured periodic education in improving postoperative self-management and recovery outcomes among older adults undergoing cataract surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sivas, Turkey (Türkiye), 58140
- Sivas Suşehri Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged 65 to 85 years
Scheduled for cataract surgery
Able to understand and respond to questions
No diagnosed psychiatric disorder
Voluntarily agreed to participate in the study
Exclusion Criteria:
Presence of another chronic eye disease
Failure to attend postoperative follow-up appointments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Periodic Education Group
Participants in this group receive structured periodic education in addition to routine postoperative care.
The education includes instruction on correct eye drop administration, medication adherence, hygiene practices, and recognition of complication symptoms, reinforced during follow-up visits on postoperative days 6, 14, and 21.
|
Participants in this group receive structured periodic education in addition to routine postoperative care.
The education includes instruction on correct eye drop administration, medication adherence, hygiene practices, and recognition of complication symptoms, reinforced during follow-up visits on postoperative days 6, 14, and 21.
Participants in this group receive standard postoperative care routinely provided in the ophthalmology clinic, including discharge instructions and scheduled follow-up visits, without additional structured education.
|
|
Active Comparator: Routine Care Group
Participants in this group receive standard postoperative care routinely provided in the ophthalmology clinic, including discharge instructions and scheduled follow-up visits, without additional structured education.
|
Participants in this group receive standard postoperative care routinely provided in the ophthalmology clinic, including discharge instructions and scheduled follow-up visits, without additional structured education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Adherence to Prescribed Eye Drops
Time Frame: Postoperative Day 28
|
Medication adherence will be assessed using the Modified Morisky Medication Adherence Scale (MMAS-6).
The MMAS-6 consists of 6 items and yields a total score ranging from 0 to 6, with higher scores indicating better medication adherence.
|
Postoperative Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vision-Related Quality of Life
Time Frame: Postoperative Day 28
|
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
The NEI VFQ-25 consists of 25 items and generates a composite score ranging from 0 to 100, with higher scores indicating better vision-related quality of life.
|
Postoperative Day 28
|
|
Postoperative Complication Rate
Time Frame: Postoperative Day 28
|
The incidence of postoperative complications (infection, inflammation, corneal edema, increased intraocular pressure, or delayed healing) will be recorded as the proportion of participants experiencing at least one complication during scheduled postoperative follow-up visits up to day 28.
|
Postoperative Day 28
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: kadriye Aldemir Atmaca, PhD, Cumhuriyet University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCU-2025-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
-
Colvard Kandavel Eye CenterEnrolling by invitationCataract | Cataract Bilateral | Cataract Surgery | Cataract (Post-operative Cataract Surgery Follow-up)United States
-
Matthew RauenNot yet recruitingNuclear Cataract | Cataract Surgery Anesthesia | Cataract and IOL Surgery | Cataract Surgery ExperienceUnited States
-
Züleyha SönmezAtaturk UniversityActive, not recruitingCataract Surgery | Cataract Patients | Cataract After SurgeryTurkey (Türkiye)
-
Stanford UniversityEnrolling by invitationIntraocular Lens | Cataract Extraction | Cataract Surgery | Eye Disorders | Cataract and IOL Surgery | Cataract Surgery ExperienceUnited States
-
Gemini Eye ClinicRecruitingBilateral Cataract | Unilateral CataractCzechia
-
Fundación Pública Andaluza para la Investigación...CompletedCataract | Cataract Mature | Cataract, Nuclear
-
Seva Canada SocietyPragyaan Sustainable Health Outcomes Foundation; Sadgura Netra ChikitsalayaNot yet recruitingCataract (Post-operative Cataract Surgery Follow-up)
-
Nicole Fram M.D.RecruitingCataract Bilateral | Nuclear Sclerosis of the Lens | Phacoemulsification Cataract SurgeryUnited States
-
Johannes Kepler University of LinzCompletedCataract Complicated | Cataract Complications OperationsAustria
-
Universitaire Ziekenhuizen KU LeuvenLaboratoires TheaRecruiting
Clinical Trials on Periodic Education
-
University of West AtticaCompletedHealthy Older Adults | Community Dwelling Older Adults | Older Adults (65 Years and Older)Greece
-
Cairo UniversityWithdrawnPolycystic Ovary Syndrome | InfertilityEgypt
-
New York Institute of TechnologyCompleted
-
Federal University of Health Science of Porto AlegreUnknownLymphoma | Leukemia | Fatigue | Physical DisabilityBrazil
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityCompletedPostoperative Complications | Abdominal Surgery | Intraoperative Mechanical VentilationChina
-
Kasr El Aini HospitalCompleted
-
New York Institute of TechnologyCompletedPhysical Activity | Sleep DisordersUnited States
-
Center for Translational MedicineUnknownPain | Balance | Stiffness | Abnormal GaitUnited States
-
University of Colorado, DenverAmerican Diabetes AssociationEnrolling by invitationType 2 Diabetes | Non Insulin Dependent DiabetesUnited States
-
TriVirum, Inc.Completed