Age Related CataractPhase 2NCT06614348
Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
A Phase 2 study testing Prednisolone acetate eye drop group and Sodium hyaluronate eye drops in people with Age Related Cataract and Pain Management During Cataract Surgery, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This study aims to evaluate the efficacy, safety, and potential mechanisms of prednisolone acetate eye drops for pain management in patients undergoing second-eye surgery for age-related cataracts. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Age Related Cataract, Pain Management During Cataract Surgery
- What is being tested?
- Prednisolone acetate eye drop group and Sodium hyaluronate eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2024to 30 Nov 2025
- Phase
- Phase 2
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50-80 years old;
- A clear diagnosis of age-related cataract, having completed the first eye cataract surgery at our hospital, and planning to have the second eye cataract surgery with the same doctor;
- The interval between the two surgeries is ≤30 days;
- Capable of cooperating to complete iris optical coherence tomography angiography examination;
- Based on our team\'s previous research, a predictive scoring formula for pain during the second eye surgery has been derived (Predicted score = 1.36 + 4.93 * preoperative iris vessel area density - 0.24 * surgical interval (weeks)), and the calculated predicted score is \>2.
Who cannot join
- History of ocular trauma, ocular surgery, uveitis, fundus disease, glaucoma, or recent history of episcleritis, keratitis, severe dry eye, and other ocular surface disease episodes;
- Participation in intraocular or systemic medication clinical trials within the past 6 months;
- Having an autoimmune disease or currently undergoing immunosuppressive therapy;
- Having a psychiatric disorder such as anxiety or depression;
- History of using glucocorticoid eye drops for treatment in the second eye within the past month;
- Long-term use of drugs that can cause intraoperative floppy iris syndrome, such as alpha-blockers;
- Severe complications occurred during or after the first eye surgery (e.g., posterior capsule rupture, zonular exercise, nuclear drop into the vitreous cavity, postoperative endophthalmitis, glaucoma, etc.).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Study of Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
This study aims to evaluate the efficacy, safety, and potential mechanisms of prednisolone acetate eye drops for pain management in patients undergoing second-eye surgery for age-related cataracts.
Researchers will compare prednisolone acetate eye drops to sodium hyaluronate eye drops to see if prednisolone acetate eye drops work to relieve intraoperative and postoperative pain during second-eye cataract surgery.
Participants will:
- Receive prednisolone acetate eye drops or sodium hyaluronate eye drop four drops within 2 hours before cataract surgery
- Finish cataract surgery and routine postoperative follow-up
- Pain questionnaire completed after cataract surgery
- Being tested
- Prednisolone acetate eye drop group, Sodium hyaluronate eye drops
- Keywords
- cataract surgery, pain, second-eye cataract surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone acetate eye drop groupDrug
Patients receive prednisolone acetate eye drops 4 times per 30min within 2 hours before cataract surgery
Sodium hyaluronate eye dropsDrug
Patients receive sodium hyaluronate eye drops 4 times per 30min within 2 hours before cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone acetate eye drop group | Experimental | Not described Receives: Drug: Prednisolone acetate eye drop group |
| hyaluronic acid eye drop group | Placebo comparator | Not described Receives: Drug: Sodium hyaluronate eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores measured by Visual Analogue Scale
Within one hour after surgery, the investigator uses the Visual Analogue Scale (VAS) to allow the patient to self-assess the degree of pain. A movable ruler about 10 cm long is used, with one side unmarked and the other side marked with scales, with the ends labeled "0" for no pain and "10" for the most severe pain that is unbearable. The investigator holds the marked side of the ruler away from the patient, allowing the patient to mark the position on the ruler that represents their level of pain. The investigator then records the corresponding score based on the position marked by the patient.
Measured: Within one hour after surgery
Secondary outcomes (4)
Comparison of pain during the second eye surgery to the first eye surgery
Within one hour after the surgery, the investigator asks the patient to compare the pain experienced during the second eye surgery with that of the first eye surgery. The patient is asked to choose the most appropriate statement from the following: 1. I think the pain during the second eye surgery was worse than the first eye surgery; 2. I think the pain during the second eye surgery was less than the first eye surgery; 3. I think the pain during the second eye surgery was about the same as the first eye surgery; 4. I do not remember the pain during the first eye surgery; and the result is recorded by the investigator.
Measured: Within one hour after surgery
Expression levels of monocyte chemotactic protein-1 in the aqueous humor of surgical eyes
The aqueous humor is detected using a cytokine array according to the instructions of manufacturer.
Measured: Within three months after surgery
Best Corrected Visual Acuity (BCVA) of the surgical eye
When testing Best Corrected Visual Acuity (BCVA) with the Snellen chart, first ensure that the patient is wearing the appropriate corrective lenses. Then ask the patient to stand 20 feet (6 meters) away from the chart. Instruct the patient to cover one eye with a hand, and test the uncovered eye. Starting from the top, have the patient read the smallest line of text they can see clearly. Record the vision of the smallest line that the patient can read completely and correctly.
Measured: One month after surgery
Adverse events and severe adverse events
Adverse Events (AEs):
Intraoperative complications: such as posterior capsule rupture, zonular dialysis, inability to implant an intraocular lens, etc.
Postoperative infection: Infection at the surgical site, which may require additional antibiotic treatment or surgical intervention.
Changes in vision: Decreased vision after surgery can occur even without apparent complications.
Elevated intraocular pressure: Intraocular pressure may be temporarily or persistently elevated after surgery, necessitating medication or surgical intervention.
Serious Adverse Events (SAEs):
Retinal detachment, endopthalmitis, persistent high intraocular pressure, severe bleeding, dislocation of the lens or intraocular lens, etc.
Measured: From enrollment to one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start8 Oct 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age Related CataractStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiyi Jin, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Huiyi Jin, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614348
- Sponsor's protocol ID
- CCTR-2023C03
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang Y, Du Y, Jiang Y, Zhu X, Lu Y. Effects of Pranoprofen on Aqueous Humor Monocyte Chemoattractant Protein-1 Level and Pain Relief During Second-Eye Cataract Surgery. Front Pharmacol. 2018 Jul 17;9:783. doi: 10.3389/fphar.2018.00783. eCollection 2018.
PubMed 30065652Cui L, Ma Y, Wang Y, Luo Q, Ding Q, Ge L, Lu S, Miao Y, Sun Q, Zou H, Jin H. Combination of iris vessel area density and surgery interval as the predictor of perceived pain during consecutive second-eye cataract surgery. J Cataract Refract Surg. 2023 Aug 1;49(8):858-863. doi: 10.1097/j.jcrs.0000000000001229.
PubMed 37350758
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
- ClinicalTrials.gov ID
- NCT06614348
- Acronym / sponsor ID
- CCTR-2023C03
- Keywords
- cataract surgery, pain, second-eye cataract surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 26 Sep 2024 (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 aims to evaluate the efficacy, safety, and potential mechanisms of prednisolone acetate eye drops for pain management in patients undergoing second-eye surgery for age-related cataracts.
Researchers will compare prednisolone acetate eye drops to sodium hyaluronate eye drops to see if prednisolone acetate eye drops work to relieve intraoperative and postoperative pain during second-eye cataract surgery.
Participants will:
- Receive prednisolone acetate eye drops or sodium hyaluronate eye drop four drops within 2 hours before cataract surgery
- Finish cataract surgery and routine postoperative follow-up
- Pain questionnaire completed after cataract surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone acetate eye drop group | Experimental | Drug: Prednisolone acetate eye drop group |
| hyaluronic acid eye drop group | Placebo comparator | Drug: Sodium hyaluronate eye drops |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 50-80 years old;
- A clear diagnosis of age-related cataract, having completed the first eye cataract surgery at our hospital, and planning to have the second eye cataract surgery with the same doctor;
- The interval between the two surgeries is ≤30 days;
- Capable of cooperating to complete iris optical coherence tomography angiography examination;
- Based on our team\'s previous research, a predictive scoring formula for pain during the second eye surgery has been derived (Predicted score = 1.36 + 4.93 * preoperative iris vessel area density - 0.24 * surgical interval (weeks)), and the calculated predicted score is \>2.
Key exclusion criteria (7 listed)
- History of ocular trauma, ocular surgery, uveitis, fundus disease, glaucoma, or recent history of episcleritis, keratitis, severe dry eye, and other ocular surface disease episodes;
- Participation in intraocular or systemic medication clinical trials within the past 6 months;
- Having an autoimmune disease or currently undergoing immunosuppressive therapy;
- Having a psychiatric disorder such as anxiety or depression;
- History of using glucocorticoid eye drops for treatment in the second eye within the past month;
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 |
|---|---|---|
| Prednisolone acetate eye drop groupPatients receive prednisolone acetate eye drops 4 times per 30min within 2 hours before cataract surgery | Drug | Prednisolone acetate eye drop group |
| Sodium hyaluronate eye dropsPatients receive sodium hyaluronate eye drops 4 times per 30min within 2 hours before cataract surgery | Drug | hyaluronic acid eye drop group |
Primary outcome
Pain scores measured by Visual Analogue Scale
Time frame: Within one hour after surgery
Within one hour after surgery, the investigator uses the Visual Analogue Scale (VAS) to allow the patient to self-assess the degree of pain. A movable ruler about 10 cm long is used, with one side unmarked and the other side marked with scales, with the ends labeled "0" for no pain and "10" for the most severe pain that is unbearable. The investigator holds the marked side of the ruler away from the patient, allowing the patient to mark the position on the ruler that represents their level of pain. The investigator then records the corresponding score based on the position marked by the patient.
4 secondary outcomes
Comparison of pain during the second eye surgery to the first eye surgery
Time frame: Within one hour after surgery
Expression levels of monocyte chemotactic protein-1 in the aqueous humor of surgical eyes
Time frame: Within three months after surgery
Best Corrected Visual Acuity (BCVA) of the surgical eye
Time frame: One month after surgery
Adverse events and severe adverse events
Time frame: From enrollment to one month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 30065652Zhang Y, Du Y, Jiang Y, Zhu X, Lu Y. Effects of Pranoprofen on Aqueous Humor Monocyte Chemoattractant Protein-1 Level and Pain Relief During Second-Eye Cataract Surgery. Front Pharmacol. 2018 Jul 17;9:783. doi: 10.3389/fphar.2018.00783. eCollection 2018.
- Background: PubMed 37350758Cui L, Ma Y, Wang Y, Luo Q, Ding Q, Ge L, Lu S, Miao Y, Sun Q, Zou H, Jin H. Combination of iris vessel area density and surgery interval as the predictor of perceived pain during consecutive second-eye cataract surgery. J Cataract Refract Surg. 2023 Aug 1;49(8):858-863. doi: 10.1097/j.jcrs.0000000000001229.
- Individual participant dataSharing planned: Undecided
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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.
Huiyi Jin principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisolone acetate eye drop group and Sodium hyaluronate eye drops in people with Age Related Cataract and Pain Management During Cataract Surgery, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 7 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiyi Jin (021-63240090, superbaby_jin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores measured by Visual Analogue Scale (time frame: Within one hour after surgery). 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 NCT06614348, which also lists 2 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 26 Sep 2024.