Study for Optimizing Anti-inflammatory Prophylaxis

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Drop-less Surgery Compared to Topical NSAID Alone and Combination of Steroid and NSAID on Central Macular Thickness After Cataract Surgery, a Randomized Controlled Trial

Conditions
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Postoperative Cystoid Macular Edema, Irvine-Gass Syndrome

Intervention / Treatment
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* Drug: NSAID + prednisolone, preoperative
* Drug: NSAID + prednisolone, postoperative
* Drug: NSAID, preoperative
* Drug: NSAID, postoperative
* Drug: Drop-less surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age-related cataracts Older than 18 years Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months. Capacity to consent Scheduled to undergo cataract surgery at the ophthalmic department at Rigshospitalet-Glostrup, Denmark The surgeon must be experienced, defined by a minimum of 1000 cataract extractions completed Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study Informed consent to participation Exclusion Criteria: Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study Medical history of epiretinal membrane, retinal vein occlusion, retinal detachment, uveitis, glaucoma, diabetes mellitus, exudative age-related macular degeneration (AMD) or AMD with geographical atrophy Significant complications to surgery such as posterior capsule rupture/vitreous loss, choroidal hemorrhage, and dislocated lens material Pregnancy Fertile women, i.e. women who are not menopausal. Women who breastfeed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSAID + prednisolone, preoperative<br>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 | Drug: NSAID + prednisolone, preoperative<br>* 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.<br>* Other names: Group a1;|
| Active Comparator: NSAID + prednisolone, postoperative<br>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 | Drug: NSAID + prednisolone, postoperative<br>* 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.<br>* Other names: Group a2;|
| Experimental: NSAID, preoperative<br>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 | Drug: NSAID, preoperative<br>* Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.<br>* Other names: Group b1;|
| Experimental: NSAID, postoperative<br>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 | Drug: NSAID, postoperative<br>* Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.<br>* Other names: Group b2;|
| Experimental: Drop-less surgery<br>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. | Drug: Drop-less surgery<br>* A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.<br>* Other names: Group c;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Cataract Surgery