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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone acetate eye drop group | Experimental |
| |
| hyaluronic acid eye drop group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone acetate eye drop group | Drug | Patients receive prednisolone acetate eye drops 4 times per 30min within 2 hours before cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within one hour after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiyi Jin | Contact | 021-63240090 | superbaby_jin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huiyi Jin | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30065652 | Background | 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. | |
| 37350758 | Background | Cui 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. |
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| Sodium hyaluronate eye drops | Drug | Patients receive sodium hyaluronate eye drops 4 times per 30min within 2 hours before cataract surgery |
|
| 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. | 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. | 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. | From enrollment to one month after surgery |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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