CataractNCT07439809
The Effect of Periodic Intensive Education on Surgical Outcomes in Cataract Surgery Patients
A study testing Periodic Education and Routine Postoperative Care in people with Cataract, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Periodic Education and Routine Postoperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2025to 30 Nov 2025
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- Presence of another chronic eye disease
- Failure to attend postoperative follow-up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Cataract
- Being tested
- Periodic Education, Routine Postoperative Care
- Keywords
- Cataract Surgery, Medication Adherence, Patient Education
- Medical subject headings
- Cataract, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodic EducationBehavioural
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.
Routine Postoperative CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Periodic Education Group | Experimental | 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. Receives: Behavioral: Periodic Education; Behavioral: Routine Postoperative Care |
| Routine Care Group | Active comparator | 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. Receives: Behavioral: Routine Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence to Prescribed Eye Drops
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.
Measured: Postoperative Day 28
Secondary outcomes (2)
Vision-Related Quality of Life
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.
Measured: Postoperative Day 28
Postoperative Complication Rate
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.
Measured: Postoperative Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start30 Jul 2025
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the periodic education group or the routine care control group and followed in parallel during the postoperative period (days 6, 14, and 21).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadriye Aldemir Atmaca, PHD, Cumhuriyet University
- Investigators
- kadriye Aldemir Atmaca, PhD, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439809
- Sponsor's protocol ID
- SCU-2025-06
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to institutional data protection policies and ethical considerations related to participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periodic Intensive Education Intervention on Surgical Outcomes in Elderly Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT07439809
- Acronym / sponsor ID
- SCU-2025-06
- Conditions
- Cataract
- Keywords
- Cataract Surgery, Medication Adherence, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 27 Feb 2026 (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 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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the periodic education group or the routine care control group and followed in parallel during the postoperative period (days 6, 14, and 21).
| Arm | Type | Receives |
|---|---|---|
| Periodic Education Group | Experimental | Behavioral: Periodic Education, Behavioral: Routine Postoperative CareParticipants 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. |
| Routine Care Group | Active comparator | Behavioral: Routine Postoperative CareParticipants 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of another chronic eye disease
- Failure to attend postoperative follow-up appointments
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 |
|---|---|---|
| Periodic EducationParticipants 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. | Behavioural | Periodic Education Group |
| Routine Postoperative CareParticipants 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. | Behavioural | Periodic Education Group, Routine Care Group |
Primary outcome
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.
2 secondary outcomes
Vision-Related Quality of Life
Time frame: Postoperative Day 28
Postoperative Complication Rate
Time frame: Postoperative Day 28
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 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to institutional data protection policies and ethical considerations related to participant privacy and confidentiality.
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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.
kadriye Aldemir Atmaca, PhD principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodic Education and Routine Postoperative Care in people with Cataract, run by Cumhuriyet 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 5 inclusion and 2 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 2 Mar 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?
Medication Adherence to Prescribed Eye Drops (time frame: Postoperative Day 28). 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 2 Mar 2026.