CataractNCT07899112
Manipulating Temporal Expectations to Accelerate Recovery After Cataract Surgery
A study testing Faster-timeline video and healing-attention surveys and Standard-timeline video and matched surveys in people with Cataract, run by Harvard University at 2 sites in United States.
Trial summary
This study tested whether changing how quickly patients expect to heal after cataract surgery changes how quickly their vision recovers. Adults having cataract surgery in both eyes were randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Faster-timeline video and healing-attention surveys and Standard-timeline video and matched surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2024to 6 Jul 2026
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for bilateral cataract surgery with the participating surgeon; within the approved age range
Who cannot join
- Rare complications or exceptionally severe cataract, as judged by the surgeon; significant pre-existing, vision-limiting retinal or corneal pathology
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Ophthalmic Consultants of Vermont
South Burlington, Vermont, 05403
About this study
Official title: Effect of Healing Time Expectations on Actual Healing Times Following Cataract Surgery
This study tested whether changing how quickly patients expect to heal after cataract surgery changes how quickly their vision recovers. Adults having cataract surgery in both eyes were randomly assigned to one of two groups. Both groups watched a short video of their surgeon before each surgery and completed short daily surveys afterwards. In one group, the video gave somewhat faster recovery timeframes and the surveys asked patients to notice day-to-day changes in their vision. In the other group, the video gave standard recovery timeframes and the surveys asked about activities and mood. Visual acuity was measured at routine clinic visits 1 day, 1 to 2 weeks, and 3 months after surgery.
Read the detailed description
Two-arm, parallel-group randomized trial with an active control. Patients scheduled for bilateral cataract surgery with one surgeon at two ophthalmology practices completed an online enrollment survey, which included informed consent, and were then randomized using a computer-generated sequence applied in order of enrollment.
The enrollment survey collected demographics, the 14-item Perceived Stress Scale, the Hospital Anxiety and Depression Scale, the 14-item Langer Mindfulness Scale, the Ten-Item Personality Inventory, a three-item study-specific measure of general healing expectations, and the NEI-VFQ-25.
One day before each surgery, participants watched a preoperative video of their surgeon and answered multiple-choice questions about its content. Beginning 48 hours after each surgery, participants received up to 10 daily surveys. Clinic staff measured visual acuity at baseline and at routine follow-up visits. Participants completed the NEI-VFQ-25 again 3 months after surgery and were then debriefed.
Participants were told the study concerned psychological factors and recovery after cataract surgery; the specific hypothesis was disclosed at debriefing. The surgeon and clinic staff who measured visual acuity were not told participants' assigned group.
Planned enrollment was 180. Enrollment closed at 147 because recruitment was slower than planned. The study was registered after data collection was complete.
- Conditions
- Cataract
- Being tested
- Faster-timeline video and healing-attention surveys, Standard-timeline video and matched surveys
- Keywords
- expectations, attention, placebo effect, postoperative recovery, visual acuity, mind-body
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faster-timeline video and healing-attention surveysBehavioural
Preoperative video of the participant's surgeon giving recovery timeframes shifted earlier than standard: blurry vision for 24 to 48 hours; noticeable improvement within 24 hours and by 5 to 7 days; irritation and light sensitivity resolving within 7 to 14 days. Watched 1 day before each surgery, followed by quiz questions on the timeframes. Then up to 10 daily surveys after each surgery, starting 48 hours post-surgery, asking participants to rate changes in vision, discomfort and daily function compared with the previous day.
Standard-timeline video and matched surveysBehavioural
Preoperative video of the same surgeon giving standard recovery timeframes: blurry vision for up to 48 hours; noticeable improvement within 48 hours and by 1 week; irritation and light sensitivity resolving within a couple of weeks. Same schedule and quiz format. Then up to 10 daily surveys after each surgery, matched in number and length, asking about activities, rest and current mood, not healing.
| Study group | Role | What they receive |
|---|---|---|
| Fast Healing | Experimental | Preoperative video giving recovery timeframes shifted earlier than standard, followed by daily surveys directing attention to day-to-day changes in healing. Receives: Behavioral: Faster-timeline video and healing-attention surveys |
| Standard healing | Active comparator | Preoperative video giving standard recovery timeframes, followed by daily surveys of matched length asking about activities and mood. Receives: Behavioral: Standard-timeline video and matched surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best-corrected visual acuity at 1 day
Snellen acuity from the routine clinic exam, converted to logMAR; change from preoperative baseline, averaged across both eyes. Lower values indicate better acuity.
Measured: Baseline to 1 day after each surgery
Change in best-corrected visual acuity at 1 to 2 weeks
Snellen acuity from the routine clinic exam, converted to logMAR; change from preoperative baseline, averaged across both eyes. Lower values indicate better acuity.
Measured: Baseline to 1 to 2 weeks after each surgery
Secondary outcomes (2)
Change in best-corrected visual acuity at 3 months
Same measure and scoring as the primary outcomes.
Measured: Baseline to 3 months after the second surgery
Change in NEI-VFQ-25 composite score
National Eye Institute Visual Function Questionnaire, 25 items; composite scored 0 to 100, higher indicates better visual function.
Measured: Enrollment to 3 months after the first surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start5 Oct 2024
- Primary completion28 Apr 2026
- Study completion6 Jul 2026
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Ophthalmic Consultants of Boston, Ophthalmic Consultants of Vermont
- Responsible party
- Principal investigator, Peter Aungle, Harvard University
- Investigators
- Peter J Aungle, Ph.D., Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899112
- Sponsor's protocol ID
- IRB23-1420
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data underlying the reported analyses, together with the analysis code, are available in a public repository (Zenodo, DOI 10.5281/zenodo.22655124).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Healing Time Expectations on Actual Healing Times Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT07899112
- Acronym / sponsor ID
- IRB23-1420
- Conditions
- Cataract
- Keywords
- expectations, attention, placebo effect, postoperative recovery, visual acuity, mind-body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- Ophthalmic Consultants of Boston, Ophthalmic Consultants of Vermont
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 27 Oct 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.
This study tested whether changing how quickly patients expect to heal after cataract surgery changes how quickly their vision recovers. Adults having cataract surgery in both eyes were randomly assigned to one of two groups. Both groups watched a short video of their surgeon before each surgery and completed short daily surveys afterwards. In one group, the video gave somewhat faster recovery timeframes and the surveys asked patients to notice day-to-day changes in their vision. In the other group, the video gave standard recovery timeframes and the surveys asked about activities and mood. Visual acuity was measured at routine clinic visits 1 day, 1 to 2 weeks, and 3 months after surgery.
Detailed description
Two-arm, parallel-group randomized trial with an active control. Patients scheduled for bilateral cataract surgery with one surgeon at two ophthalmology practices completed an online enrollment survey, which included informed consent, and were then randomized using a computer-generated sequence applied in order of enrollment.
The enrollment survey collected demographics, the 14-item Perceived Stress Scale, the Hospital Anxiety and Depression Scale, the 14-item Langer Mindfulness Scale, the Ten-Item Personality Inventory, a three-item study-specific measure of general healing expectations, and the NEI-VFQ-25.
One day before each surgery, participants watched a preoperative video of their surgeon and answered multiple-choice questions about its content. Beginning 48 hours after each surgery, participants received up to 10 daily surveys. Clinic staff measured visual acuity at baseline and at routine follow-up visits. Participants completed the NEI-VFQ-25 again 3 months after surgery and were then debriefed.
Participants were told the study concerned psychological factors and recovery after cataract surgery; the specific hypothesis was disclosed at debriefing. The surgeon and clinic staff who measured visual acuity were not told participants' assigned group.
Planned enrollment was 180. Enrollment closed at 147 because recruitment was slower than planned. The study was registered after data collection was complete.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast Healing | Experimental | Behavioral: Faster-timeline video and healing-attention surveysPreoperative video giving recovery timeframes shifted earlier than standard, followed by daily surveys directing attention to day-to-day changes in healing. |
| Standard healing | Active comparator | Behavioral: Standard-timeline video and matched surveysPreoperative video giving standard recovery timeframes, followed by daily surveys of matched length asking about activities and mood. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for bilateral cataract surgery with the participating surgeon; within the approved age range
Key exclusion criteria (1 listed)
- Rare complications or exceptionally severe cataract, as judged by the surgeon; significant pre-existing, vision-limiting retinal or corneal pathology
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 |
|---|---|---|
| Faster-timeline video and healing-attention surveysPreoperative video of the participant's surgeon giving recovery timeframes shifted earlier than standard: blurry vision for 24 to 48 hours; noticeable improvement within 24 hours and by 5 to 7 days; irritation and light sensitivity resolving within 7 to 14 days. Watched 1 day before each surgery, followed by quiz questions on the timeframes. Then up to 10 daily surveys after each surgery, starting 48 hours post-surgery, asking participants to rate changes in vision, discomfort and daily function compared with the previous day. | Behavioural | Fast Healing |
| Standard-timeline video and matched surveysPreoperative video of the same surgeon giving standard recovery timeframes: blurry vision for up to 48 hours; noticeable improvement within 48 hours and by 1 week; irritation and light sensitivity resolving within a couple of weeks. Same schedule and quiz format. Then up to 10 daily surveys after each surgery, matched in number and length, asking about activities, rest and current mood, not healing. | Behavioural | Standard healing |
Primary outcome
Change in best-corrected visual acuity at 1 day
Time frame: Baseline to 1 day after each surgery
Snellen acuity from the routine clinic exam, converted to logMAR; change from preoperative baseline, averaged across both eyes. Lower values indicate better acuity.
Change in best-corrected visual acuity at 1 to 2 weeks
Time frame: Baseline to 1 to 2 weeks after each surgery
Snellen acuity from the routine clinic exam, converted to logMAR; change from preoperative baseline, averaged across both eyes. Lower values indicate better acuity.
2 secondary outcomes
Change in best-corrected visual acuity at 3 months
Time frame: Baseline to 3 months after the second surgery
Change in NEI-VFQ-25 composite score
Time frame: Enrollment to 3 months after the first surgery
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data underlying the reported analyses, together with the analysis code, are available in a public repository (Zenodo, DOI 10.5281/zenodo.22655124).
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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.
Peter J Aungle, Ph.D. principal investigator
Harvard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faster-timeline video and healing-attention surveys and Standard-timeline video and matched surveys in people with Cataract, run by Harvard University at 2 sites in United States.
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 1 inclusion and 1 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Change in best-corrected visual acuity at 1 day (time frame: Baseline to 1 day after each 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?
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 27 Oct 2026.