Study for Optimizing Anti-inflammatory Prophylaxis

Irvine-Gass Syndrome Clinical Trial

— SOAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383328
• Other study ID #: SOAP1
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: December 18, 2019

Study information

• Verified date: December 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irvine-Gass Syndrome
• Macular Edema
• Postoperative Cystoid Macular Edema

Intervention

Drug:
• NSAID + 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.
• NSAID + 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.
• NSAID, 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.
• NSAID, 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.
• Drop-less surgery
A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology	Glostrup	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Line Kessel

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickness	Change in central macular thickness (CMT) measured by optical coherence tomography 3 months after cataract surgery.	3 months
Secondary	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
Secondary	Intraocular pressure	Change in intraocular pressure	3 days, 3 weeks and 3 months
Secondary	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
Secondary	Flare and number of cells	Flare and number of cells measured by laser flare-cell photometry	3 days
Secondary	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
Secondary	Patient related outcome measures	Visual function questionnaires are filled out at baseline and 3 months after surgery	3 months