Cataract Surgery DeneyimiNCT07807761
Katarak Surgery and Care
An observational study of Cataract Surgery Deneyimi and Cataract Surgery, run by Eastern Mediterranean University.
Trial summary
Although cataract surgery is an effective treatment method for improving visual function, it is important to evaluate the quality of life, daily living activities, independence level and psychosocial well-being of patients in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Surgery Deneyimi, Cataract Surgery
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 1 Jun 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18 years and older who are scheduled to undergo cataract surgery at Dr. Burhan Nalbantoğlu State Hospital, Nicosia, Northern Cyprus.
Inclusion Criteria Adults aged 18 years or older. Patients scheduled for cataract surgery. Able to communicate in Turkish and complete the questionnaires. Willing to participate voluntarily and provide informed consent. Willing to attend postoperative follow-up assessments at 1 and 3 months. Exclusion Criteria Presence of other ocular diseases that significantly affect visual function (e.g., advanced glaucoma, macular degeneration, or severe retinal disease).
Cognitive or communication problems that prevent completion of the questionnaires.
Development of a serious postoperative complication. Failure to complete the scheduled follow-up assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gülten Sucu Dağ, Prof. contact
About this study
Official title: Fear of Falling and Vision-Related Quality of Life of Patients Before and After Cataract Surgery, Evaluation of Postoperative Care Compliance: A Prospective Longitudinal Study
Although cataract surgery is an effective treatment method for improving visual function, it is important to evaluate the quality of life, daily living activities, independence level and psychosocial well-being of patients in the postoperative period. Changes in visual function can affect individuals' ability to live their daily lives, their perception of the risk of falling, and their adaptation to post-treatment care processes. For this reason, the recovery process after cataract surgery should be evaluated not only with clinical results, but also with patient-centered outcome criteria. The aim of this research is to investigate the preoperative and postoperative period in patients undergoing cataract surgery 1. and 3. The aim is to prospectively evaluate changes in care compliance, fear of falling, and vision-related quality of life during monthly follow-ups.
Read the detailed description
Cataract surgery is one of the most commonly performed and most successful surgical procedures worldwide, and it is performed on more than 20 million individuals every year (Lundström et al., 2021). Age-related cataract is a condition that develops as a result of the loss of transparency of the lens of the eye, especially in the older age group, and is considered one of the leading causes of vision loss on a global scale (World Health Organization [WHO], 2025). Although cataract surgery is performed in order to restore visual function and increase an individual's visual capacity, it is stated that surgical success should not be evaluated solely by clinical indicators such as visual acuity; its effects on an individual's daily life activities, level of independence, and visual-related quality of life should also be taken into account. Current studies have shown that cataract surgery provides significant improvement in vision-related quality of life and positively affects the functional status of individuals
- Conditions
- Cataract Surgery Deneyimi, Cataract Surgery
- Keywords
- Cataract; Cataract Surgery; Fear of Falling; Vision-Related Quality of Life; NEI-VFQ-25; Postoperative Care; Care Adherence; Visual Function
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cataract Surgery Group | Description: A single cohort of patients undergoing cataract surgery will be followed prospectively from the preoperative period to 1 and 3 months after surgery. No research intervention will be administered. Participants undergoing cataract surgery will be followed prospectively from the preoperative period to 1 and 3 months after surgery. Fear of falling, vision-related quality of life, and postoperative care adherence will be assessed at the predefined follow-up time points. No additional intervention will be administered by the researchers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure: Change in Vision-Related Quality of Life
Change in vision-related quality of life from the preoperative assessment to 3 months after cataract surgery, measured using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). Higher scores indicate better vision-related quality of life.
Measured: Baseline (preoperative) to 3 months after cataract surgery
Primary Outcome Measure: Vision-related quality of life measured by the NEI-VFQ-25
Change in vision-related quality of life from the preoperative assessment to 1 month and 3 months after cataract surgery, measured using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25).
Measured: Baseline (preoperative), 1 month, and 3 months after cataract surgery
Secondary outcomes (2)
Outcome Measure: Fear of falling measured by the Falls Efficacy Scale-International (FES-I)
Fear of falling will be assessed before and 3 months after cataract surgery.
Measured: Time Frame: Baseline (preoperative) and 3 months after cataract surgery
Outcome Measure: Postoperative care adherence measured by the researcher-developed Cataract Surgery Postoperative Care Adherence Form
Postoperative adherence to recommended eye care and follow-up practices will be assessed at 1 and 3 months after cataract surgery.
Measured: Time Frame: 1 month and 3 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion21 Sep 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cataract Surgery DeneyimiStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Dürüst Sakallı, Eastern Mediterranean University
- Investigators
- Dilber Keskinel, Dr., Study chair, Bağsız
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807761
- Sponsor's protocol ID
- DoğuMU-SBF-HB-GDS-04
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. Individual participant data (IPD) will not be shared with other researchers.
Publications
Tan Y, Liu L, Li J, Qin Y, Sun A, Wu M. Effect of cataract surgery on vision-related quality of life among cataract patients with high myopia: a prospective, case-control observational study. Eye (Lond). 2022 Aug;36(8):1583-1589. doi: 10.1038/s41433-021-01697-6. Epub 2021 Jul 21.
PubMed 34290442Wan Y, Zhao L, Huang C, Xu Y, Sun M, Yang Y, An L, Lv S, Yu Y, Chen D, Zhou P, Wang Y, Zhang M, Jiang A, Chen Z, Li X. Validation and comparison of the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) and the Visual Function Index-14 (VF-14) in patients with cataracts: a multicentre study. Acta Ophthalmol. 2021 Jun;99(4):e480-e488. doi: 10.1111/aos.14606. Epub 2020 Sep 17.
PubMed 32940410Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD; National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001 Jul;119(7):1050-8. doi: 10.1001/archopht.119.7.1050.
PubMed 11448327Makabe K, Oshika T, Inamura M, Hayashi K, Sugita G, Kozawa T, Fujishima K. Influence of cataract surgery for the first or second eye on vision-related quality of life (VR-QOL) and the predictive factors of VR-QOL improvement. Jpn J Ophthalmol. 2020 Sep;64(5):468-477. doi: 10.1007/s10384-020-00762-z. Epub 2020 Aug 2.
PubMed 32743787Groessl EJ, Liu L, Sklar M, Tally SR, Kaplan RM, Ganiats TG. Measuring the impact of cataract surgery on generic and vision-specific quality of life. Qual Life Res. 2013 Aug;22(6):1405-14. doi: 10.1007/s11136-012-0270-z. Epub 2012 Sep 27.
PubMed 23015266
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Falling and Vision-Related Quality of Life of Patients Before and After Cataract Surgery, Evaluation of Postoperative Care Compliance: A Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT07807761
- Acronym / sponsor ID
- DoğuMU-SBF-HB-GDS-04
- Conditions
- Cataract Surgery Deneyimi, Cataract Surgery
- Keywords
- Cataract; Cataract Surgery; Fear of Falling; Vision-Related Quality of Life; NEI-VFQ-25; Postoperative Care; Care Adherence; Visual Function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 Sep 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.
Although cataract surgery is an effective treatment method for improving visual function, it is important to evaluate the quality of life, daily living activities, independence level and psychosocial well-being of patients in the postoperative period. Changes in visual function can affect individuals' ability to live their daily lives, their perception of the risk of falling, and their adaptation to post-treatment care processes. For this reason, the recovery process after cataract surgery should be evaluated not only with clinical results, but also with patient-centered outcome criteria. The aim of this research is to investigate the preoperative and postoperative period in patients undergoing cataract surgery 1. and 3. The aim is to prospectively evaluate changes in care compliance, fear of falling, and vision-related quality of life during monthly follow-ups.
Detailed description
Cataract surgery is one of the most commonly performed and most successful surgical procedures worldwide, and it is performed on more than 20 million individuals every year (Lundström et al., 2021). Age-related cataract is a condition that develops as a result of the loss of transparency of the lens of the eye, especially in the older age group, and is considered one of the leading causes of vision loss on a global scale (World Health Organization [WHO], 2025). Although cataract surgery is performed in order to restore visual function and increase an individual's visual capacity, it is stated that surgical success should not be evaluated solely by clinical indicators such as visual acuity; its effects on an individual's daily life activities, level of independence, and visual-related quality of life should also be taken into account. Current studies have shown that cataract surgery provides significant improvement in vision-related quality of life and positively affects the functional status of individuals
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract Surgery Group | – | –Description: A single cohort of patients undergoing cataract surgery will be followed prospectively from the preoperative period to 1 and 3 months after surgery. No research intervention will be administered. Participants undergoing cataract surgery will be followed prospectively from the preoperative period to 1 and 3 months after surgery. Fear of falling, vision-related quality of life, and postoperative care adherence will be assessed at the predefined follow-up time points. No additional intervention will be administered by the researchers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years and older who are scheduled to undergo cataract surgery at Dr. Burhan Nalbantoğlu State Hospital, Nicosia, Northern Cyprus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Outcome Measure: Change in Vision-Related Quality of Life
Time frame: Baseline (preoperative) to 3 months after cataract surgery
Change in vision-related quality of life from the preoperative assessment to 3 months after cataract surgery, measured using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). Higher scores indicate better vision-related quality of life.
Primary Outcome Measure: Vision-related quality of life measured by the NEI-VFQ-25
Time frame: Baseline (preoperative), 1 month, and 3 months after cataract surgery
Change in vision-related quality of life from the preoperative assessment to 1 month and 3 months after cataract surgery, measured using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25).
2 secondary outcomes
Outcome Measure: Fear of falling measured by the Falls Efficacy Scale-International (FES-I)
Time frame: Time Frame: Baseline (preoperative) and 3 months after cataract surgery
Outcome Measure: Postoperative care adherence measured by the researcher-developed Cataract Surgery Postoperative Care Adherence Form
Time frame: Time Frame: 1 month and 3 months after cataract surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Results publication: PubMed 34290442Tan Y, Liu L, Li J, Qin Y, Sun A, Wu M. Effect of cataract surgery on vision-related quality of life among cataract patients with high myopia: a prospective, case-control observational study. Eye (Lond). 2022 Aug;36(8):1583-1589. doi: 10.1038/s41433-021-01697-6. Epub 2021 Jul 21.
- Results publication: PubMed 32940410Wan Y, Zhao L, Huang C, Xu Y, Sun M, Yang Y, An L, Lv S, Yu Y, Chen D, Zhou P, Wang Y, Zhang M, Jiang A, Chen Z, Li X. Validation and comparison of the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) and the Visual Function Index-14 (VF-14) in patients with cataracts: a multicentre study. Acta Ophthalmol. 2021 Jun;99(4):e480-e488. doi: 10.1111/aos.14606. Epub 2020 Sep 17.
- Results publication: PubMed 11448327Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD; National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001 Jul;119(7):1050-8. doi: 10.1001/archopht.119.7.1050.
- Results publication: PubMed 32743787Makabe K, Oshika T, Inamura M, Hayashi K, Sugita G, Kozawa T, Fujishima K. Influence of cataract surgery for the first or second eye on vision-related quality of life (VR-QOL) and the predictive factors of VR-QOL improvement. Jpn J Ophthalmol. 2020 Sep;64(5):468-477. doi: 10.1007/s10384-020-00762-z. Epub 2020 Aug 2.
- Results publication: PubMed 23015266Groessl EJ, Liu L, Sklar M, Tally SR, Kaplan RM, Ganiats TG. Measuring the impact of cataract surgery on generic and vision-specific quality of life. Qual Life Res. 2013 Aug;22(6):1405-14. doi: 10.1007/s11136-012-0270-z. Epub 2012 Sep 27.
- This prospective study evaluated changes in vision-related quality of life before and after cataract surgery using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not applicable. Individual participant data (IPD) will not be shared with other researchers.
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.
Gülten Sucu Dağ, Prof. contact
Dilber Keskinel, Dr. study chair
Bağsız
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Surgery Deneyimi and Cataract Surgery, run by Eastern Mediterranean University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GÜLCAN Dürüst DÜRÜST SAKALLI (05428789621, gulcan.durust@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure: Change in Vision-Related Quality of Life (time frame: Baseline (preoperative) to 3 months after 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 NCT07807761, which also lists 5 linked publications.
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 8 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.