Irvine-Gass Syndrome, Postoperative Cystoid Macular Edema
Conditions
Keywords
Cataract, Cataract Surgery
Brief summary
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.
Interventions
DRUGNSAID + prednisolone, preoperative
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.
DRUGNSAID + prednisolone, postoperative
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.
DRUGNSAID, preoperative
Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.
DRUGNSAID, postoperative
Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.
DRUGDrop-less surgery
A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.
Sponsors
Line Kessel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness | 3 months | Change in central macular thickness (CMT) measured by optical coherence tomography 3 months after cataract surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | 3 days, 3 weeks and 3 months | Change in intraocular pressure |
| Optical nerve damage | 3 weeks and 3 months | Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT) |
| Best corrected visual acuity | 3 days, 3 weeks and 3 months | Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR) |
| Subjective patient tolerance | 3 days and 3 weeks | 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. |
| Patient related outcome measures | 3 months | Visual function questionnaires are filled out at baseline and 3 months after surgery |
| Flare and number of cells | 3 days | Flare and number of cells measured by laser flare-cell photometry |
Countries
Denmark
Outcome results
None listed