Age Related CataractPhase 4NCT07291089
Iris Vascular Area Density-Based Preoperative Pain-Risk Screening and Intervention in Second-Eye Cataract Surgery
A Phase 4 study testing Pranoprofen eye drops, Prednisolone acetate eye drops 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 at 1 site in China.
Trial summary
This clinical trial aims to evaluate the effectiveness of pranoprofen or 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 years and older
- Conditions the study is for
- Age Related Cataract, Pain Management During Cataract Surgery
- What is being tested?
- Pranoprofen eye drops, Prednisolone acetate eye drops and Sodium hyaluronate eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2024to 31 Dec 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 50 years.
- Definite diagnosis of age-related cataract.
- The first-eye cataract surgery under local anesthesia has been completed at this hospital, and the second-eye cataract surgery under local anesthesia is planned with the same surgeon within 1 year of the first-eye surgery.
- Able to cooperate with preoperative iris optical coherence tomography angiography (OCTA) examination of the operative eye.
- On the day of the second-eye surgery, preoperative iris vascular area density (VAD) ≥ 0.2167 in the operative eye.
Who cannot join
- History of ocular trauma, ocular surgery (excluding the first-eye cataract surgery already performed), uveitis, chorioretinal disease, glaucoma;
- Presence of significant corneal disease, marked iris abnormalities, or any active ocular surface disease, including recent conjunctivitis, keratitis, or severe dry eye.
- Severe complications during or after the first-eye surgery (e.g., posterior capsule rupture, zonular dialysis, dislocation of the lens nucleus into the vitreous cavity, postoperative endophthalmitis, or glaucoma).
- History of chronic pain syndromes or neuropathic pain.
- Long-term use of opioids, other systemic analgesics, or sedative-hypnotic drugs.
- Known autoimmune disease or ongoing immunosuppressive therapy.
Show all 11Show fewer
- Severe psychiatric disorders or cognitive impairment interfering with pain assessment.
- Use of topical corticosteroid eye drops in the second eye within 1 month prior to the planned surgery.
- Long-term use of α-adrenergic blockers or other medications associated with intraoperative floppy iris syndrome (IFIS).
- Participation in any other clinical trial involving ophthalmic or systemic drugs within the past 6 months.
- Known allergy or contraindication to topical nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., pranoprofen) or topical corticosteroids (e.g., prednisolone acetate) used in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200080
About this study
Official title: Preoperative Pain-Risk Screening and Intervention for Intraoperative Pain in Second-Eye Cataract Surgery Based on Iris Vascular Area Density
This clinical trial aims to evaluate the effectiveness of pranoprofen or prednisolone acetate eye drops for pain management in patients undergoing second-eye surgery for age-related cataracts. Researchers will compare pranoprofen or prednisolone acetate eye drops with sodium hyaluronate eye drops to determine whether pranoprofen or prednisolone acetate eye drops can relieve intraoperative pain during second-eye cataract surgery.
Participants will:
- Receive one drop in the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery (pranoprofen, prednisolone acetate, or sodium hyaluronate)
- Undergo cataract surgery and routine postoperative follow-up
- Within 1 hour after surgery, provide a pain visual analog scale (VAS) score under the guidance of the investigator
- Being tested
- Pranoprofen eye drops, Prednisolone acetate eye drops, 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.
Pranoprofen eye dropsDrug
Participants receive one drop of pranoprofen instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery.
Prednisolone acetate eye dropsDrug
Participants receive one drop of prednisolone acetate instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery.
Sodium hyaluronate eye dropsDrug
Participants receive one drop of sodium hyaluronate instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pranoprofen ophthalmic solution group | Experimental | Not described Receives: Drug: Pranoprofen eye drops |
| Prednisolone acetate ophthalmic suspension group | Experimental | Not described Receives: Drug: Prednisolone acetate eye drops |
| Sodium hyaluronate ophthalmic solution 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.
Proportion of Participants With Intraoperative Pain VAS ≥ 3 (Significant Pain)
Intraoperative pain is assessed within 1 hour after surgery using a 0-10 visual analog scale (VAS; 0 = no pain, 10 = most severe pain). The investigator presents the unmarked side to the participant to mark perceived intraoperative pain; the investigator reads the corresponding value on the marked reverse side and records the score. The primary endpoint is the proportion of participants with VAS ≥ 3.
Measured: Within 1 hour after surgery
Secondary outcomes (2)
Intraoperative Pain VAS Score
VAS score on a 0-10 scale, obtained with the same standardized method as the primary outcome.
Measured: Within 1 hour after surgery
Patient-Reported Comparison of Second-Eye vs First-Eye Intraoperative Pain
Within 1 hour after surgery, participants are asked to select one statement that best describes how pain during the second-eye surgery compares with their first-eye experience:
- "More painful than the first eye";
- "Less painful than the first eye";
- "About the same as the first eye";
- "I do not remember the pain during the first eye." The selected response is recorded.
Measured: Within 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start23 Feb 2024
- Primary completion20 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age Related 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiyi Jin, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291089
- Sponsor's protocol ID
- CCTR-2023C03-R
- Status last verified
- Feb 2026
- First submitted
- 6 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu XJ, Wolff D, Zhang KK, He WW, Sun XH, Lu Y, Zhou P. Molecular Inflammation in the Contralateral Eye After Cataract Surgery in the First Eye. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5566-73. doi: 10.1167/iovs.15-16531.
PubMed 26305528Zhang 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Pain-Risk Screening and Intervention for Intraoperative Pain in Second-Eye Cataract Surgery Based on Iris Vascular Area Density
- ClinicalTrials.gov ID
- NCT07291089
- Acronym / sponsor ID
- CCTR-2023C03-R
- Keywords
- Cataract surgery, Pain, Second-eye cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Dec 2025 (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 clinical trial aims to evaluate the effectiveness of pranoprofen or prednisolone acetate eye drops for pain management in patients undergoing second-eye surgery for age-related cataracts. Researchers will compare pranoprofen or prednisolone acetate eye drops with sodium hyaluronate eye drops to determine whether pranoprofen or prednisolone acetate eye drops can relieve intraoperative pain during second-eye cataract surgery.
Participants will:
- Receive one drop in the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery (pranoprofen, prednisolone acetate, or sodium hyaluronate)
- Undergo cataract surgery and routine postoperative follow-up
- Within 1 hour after surgery, provide a pain visual analog scale (VAS) score under the guidance of the investigator
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pranoprofen ophthalmic solution group | Experimental | Drug: Pranoprofen eye drops |
| Prednisolone acetate ophthalmic suspension group | Experimental | Drug: Prednisolone acetate eye drops |
| Sodium hyaluronate ophthalmic solution group | Placebo comparator | Drug: Sodium hyaluronate eye drops |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 50 years.
- Definite diagnosis of age-related cataract.
- The first-eye cataract surgery under local anesthesia has been completed at this hospital, and the second-eye cataract surgery under local anesthesia is planned with the same surgeon within 1 year of the first-eye surgery.
- Able to cooperate with preoperative iris optical coherence tomography angiography (OCTA) examination of the operative eye.
- On the day of the second-eye surgery, preoperative iris vascular area density (VAD) ≥ 0.2167 in the operative eye.
Key exclusion criteria (11 listed)
- History of ocular trauma, ocular surgery (excluding the first-eye cataract surgery already performed), uveitis, chorioretinal disease, glaucoma;
- Presence of significant corneal disease, marked iris abnormalities, or any active ocular surface disease, including recent conjunctivitis, keratitis, or severe dry eye.
- Severe complications during or after the first-eye surgery (e.g., posterior capsule rupture, zonular dialysis, dislocation of the lens nucleus into the vitreous cavity, postoperative endophthalmitis, or glaucoma).
- History of chronic pain syndromes or neuropathic pain.
- Long-term use of opioids, other systemic analgesics, or sedative-hypnotic drugs.
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 |
|---|---|---|
| Pranoprofen eye dropsParticipants receive one drop of pranoprofen instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery. | Drug | Pranoprofen ophthalmic solution group |
| Prednisolone acetate eye dropsParticipants receive one drop of prednisolone acetate instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery. | Drug | Prednisolone acetate ophthalmic suspension group |
| Sodium hyaluronate eye dropsParticipants receive one drop of sodium hyaluronate instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery. | Drug | Sodium hyaluronate ophthalmic solution group |
Primary outcome
Proportion of Participants With Intraoperative Pain VAS ≥ 3 (Significant Pain)
Time frame: Within 1 hour after surgery
Intraoperative pain is assessed within 1 hour after surgery using a 0-10 visual analog scale (VAS; 0 = no pain, 10 = most severe pain). The investigator presents the unmarked side to the participant to mark perceived intraoperative pain; the investigator reads the corresponding value on the marked reverse side and records the score. The primary endpoint is the proportion of participants with VAS ≥ 3.
2 secondary outcomes
Intraoperative Pain VAS Score
Time frame: Within 1 hour after surgery
Patient-Reported Comparison of Second-Eye vs First-Eye Intraoperative Pain
Time frame: Within 1 hour after 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 24 Feb 2026.
- Background: PubMed 26305528Zhu XJ, Wolff D, Zhang KK, He WW, Sun XH, Lu Y, Zhou P. Molecular Inflammation in the Contralateral Eye After Cataract Surgery in the First Eye. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5566-73. doi: 10.1167/iovs.15-16531.
- 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
Related trials for Age Related Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Recruiting
Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice
Vision Impairment and Blindness, Glaucoma
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Age Related Cataracts
Active, not recruitingObservational study
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
Lens Diseases, Cataract
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pranoprofen eye drops, Prednisolone acetate eye drops 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 at 1 site in China.
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 11 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 24 Feb 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of Participants With Intraoperative Pain VAS ≥ 3 (Significant Pain) (time frame: Within 1 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 NCT07291089, which also lists 3 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 24 Feb 2026.