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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-001 | Other Identifier | Oblastnà nemocnice KolÃn a.s. |
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The goal of this clinical trial is to learn which of the drugs bromfenac 0.09%, nepafenac 0.3% and diclofenac 0.1% has better efficacy in treatment and prevention of cystoid macular oedema after cataract surgery.
The main questions it aims to answer are:
Which of the drugs has better efficacy in macular oedema prevention? What medical problems do participants have when taking different drugs? Researchers will compare drugs to each other.
Participants will:
Take on of the drugs (randomized) as their treatment in preoperative and postoperative period.
Visit the clinic after the surgery on the first day, first week, in three weeks and in six weeks.
Undergo retina examination with OCT (optical coherence tomography), best vision, and fill in forms considering their quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bromfenac 0.09% | Active Comparator | Subjects will instill one drop into the study (operative) eye twice per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. |
|
| nepafenac 0.3% | Active Comparator | Subjects will instill one drop into the study (operative) eye once per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. |
|
| diclofenac 0.1% | Active Comparator | Subjects will instill one drop into the study (operative) eye four times per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromfenac 0.09 % Ophthalmic Solution | Drug | Comparison of bromfenac ophthalmic solution 0.09% twice per day vs. nepafenac ophthalmic suspension 0.3% once per day vs. diclofenac ophthalmic suspension 0.1% four times per day for prevention of cystoid macular oedema associated with cataract surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Cystoid macular oedema presence | Measured as central retinal thickness in OCT (optical coherence tomography) | From enrollment to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life change with National Eye Institute Visual Function Questionnaire | Measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases | From enrollment to the end of the treatment at 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomas Vanek | Contact | +420728872150 | tomas.vanek@nemocnicekolin.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oblastnà nemocnice KolÃn a.s. | Recruiting | KolÃn | 28002 | Czechia |
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| Nepafenac 0.3% Oph Susp | Drug | Comparison of bromfenac ophthalmic solution 0.09% twice per day vs. nepafenac ophthalmic suspension 0.3% once per day vs. diclofenac ophthalmic suspension 0.1% four times per day for prevention of cystoid macular oedema associated with cataract surgery. |
|
|
| diclofenac 0.1% ophthalmic susp. | Drug | Comparison of bromfenac ophthalmic solution 0.09% twice per day vs. nepafenac ophthalmic suspension 0.3% once per day vs. diclofenac ophthalmic suspension 0.1% four times per day for prevention of cystoid macular oedema associated with cataract surgery. |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
| D009883 | Ophthalmic Solutions |
| C414203 | nepafenac |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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