The Effect of Periodic Intensive Education on Surgical Outcomes in Cataract Surgery Patients

February 27, 2026 updated by: Kadriye Aldemir Atmaca, PHD, Cumhuriyet University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Periodic Education
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.
Behavioral: Routine Postoperative Care
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.
Behavioral: Routine Postoperative Care
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cumhuriyet University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: kadriye Aldemir Atmaca, PhD, Cumhuriyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCU-2025-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available due to institutional data protection policies and ethical considerations related to participant privacy and confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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