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The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAID + prednisolone, preoperative | Active Comparator | Combination of NSAID- and prednisolone eye drops. Treatment is initiated 3 days prior to surgery and administered 3 times pr. day for 3 weeks. Ketorolactrometamol 5 mg/ml, eye drops, 1 drop 3 times pr. day Prednisolone acetate 1% w/v, eye drops, 1 drop 3 times pr. day |
|
| NSAID + prednisolone, postoperative | Active Comparator | Combination of NSAID- and prednisolone eye drops. Treatment is initiated on the day of surgery and administered 3 times pr. day for 3 weeks. Ketorolactrometamol 5 mg/ml, eye drops, 1 drop 3 times pr. day Prednisolone acetate 1% w/v, eye drops, 1 drop 3 times pr. day |
|
| NSAID, preoperative | Experimental | NSAID eye drops as monotherapy. Treatment is initiated 3 days prior to surgery and administered 3 times pr. day for 3 weeks. Ketorolactrometamol 5 mg/ml, eye drops, 1 drop 3 times pr. day |
|
| NSAID, postoperative | Experimental | NSAID eye drops as monotherapy. Treatment is initiated on the day of surgery and administered 3 times pr. day for 3 weeks. Ketorolactrometamol 5 mg/ml, eye drops, 1 drop 3 times pr. day |
|
| Drop-less surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NSAID + prednisolone, preoperative | Drug | Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Central macular thickness | Change in central macular thickness (CMT) measured by optical coherence tomography 3 months after cataract surgery. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR) | 3 days, 3 weeks and 3 months |
| Intraocular pressure | Change in intraocular pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Line Kessel, MD, Ph.D. | Dpt. of Ophthalmology, Rigshospitalet-Glostrup | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology | Glostrup Municipality | Capital Region | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34383010 | Derived | Erichsen JH, Holm LM, Forslund Jacobsen M, Forman JL, Kessel L. Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Oct 1;139(10):1062-1070. doi: 10.1001/jamaophthalmol.2021.2976. | |
| 33086290 | Derived |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D011239 | Prednisolone |
| D011184 | Postoperative Period |
| D055749 | SOXB2 Transcription Factors |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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| Experimental |
A depot of dexamethasone is administered subtenonally during surgery. Dexamethason Krka 4 mg/ml solution for injection/infusion. 0,5 ml equivalent to 2 mg of dexamethasone is administered once. |
|
|
| NSAID + prednisolone, postoperative | Drug | Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery. |
|
|
| NSAID, preoperative | Drug | Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery. |
|
|
| NSAID, postoperative | Drug | Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery. |
|
|
| Drop-less surgery | Drug | A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery. |
|
|
| 3 days, 3 weeks and 3 months |
| Optical nerve damage | Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT) | 3 weeks and 3 months |
| Flare and number of cells | Flare and number of cells measured by laser flare-cell photometry | 3 days |
| Subjective patient tolerance | Subjective patient tolerance of prophylactic treatment measured on a 4-point analog scale, where 0 = no discomfort, 1 = mild discomfort, 2 = moderate discomfort and 3 = severe discomfort. | 3 days and 3 weeks |
| Patient related outcome measures | Visual function questionnaires are filled out at baseline and 3 months after surgery | 3 months |
| Erichsen JH, Forman JL, Holm LM, Kessel L. Effect of anti-inflammatory regimen on early postoperative inflammation after cataract surgery. J Cataract Refract Surg. 2021 Mar 1;47(3):323-330. doi: 10.1097/j.jcrs.0000000000000455. |
| D007905 |
| Lens Diseases |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D055747 | SOX Transcription Factors |
| D004268 | DNA-Binding Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006609 | High Mobility Group Proteins |
| D002868 | Chromosomal Proteins, Non-Histone |
| D009687 | Nuclear Proteins |
| D009698 | Nucleoproteins |
| D014157 | Transcription Factors |