Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)

Cataract Surgery Clinical Trial

— pre-CIN  

Official title:

A Randomized Clinical Three-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Preoperative and Postoperative Topical NSAIDs to Only Postoperative Topical NSAIDs to Postoperative Topical NSAIDs and Steroids in Patients Undergoing Cataract Surgery (Pre-CIN).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05331690
• Other study ID #: 93944
• Secondary ID: 2020-003407-34
• Status: Recruiting
• Phase: Phase 4
• Start date: November 25, 2022
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Oslo University Hospital
• Contact: Olav Kristianslund, MD PhD
• Phone: +4722118545
• Email: olakri[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pre-CIN trial is a randomized clinical three-arm trial comparing inflammation and cystoid macular edema for the medication regimens preoperative and postoperative topical NSAIDs to only postoperative topical NSAIDs to postoperative topical NSAIDs and steroids in patients undergoing cataract surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
• Scheduled for standard phacoemulsification cataract surgery (group 1 - 3)
• Scheduled for combined phacoemulsification cataract surgery and MIGS stent (group 4)
• Ability to cooperate fairly well during the examinations
• Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

• Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
• Pregnancy
• Diabetes
• Mature cataract
• Active or chronic uveitis with recommendation for steroid treatment
• Previous trabeculectomy
• Other ophthalmological conditions and/or complicating factors requiring steroid treatment (group 1 - 3)
• Cornea pathology requiring specific medication regimens (e.g. herpes pathology, previous corneal transplantation) Patients with complications or other complicating factors during surgery that causes the surgeon to demand both NSAIDs and steroid treatment will be excluded from the main analysis. These patients will be followed postoperatively as part of the study and included in additional analyses (for example as part of an intention to treat analysis). For patients scheduled for cataract surgery in both eyes, only the first operated eye will be included, however, both eyes will be examined.

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Inflammation

Intervention

Drug:
• Nepafenac Ophthalmic
Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery
• Nepafenac Ophthalmic
Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery
• Dexamethasone Ophthalmic
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery

Locations

Country	Name	City	State
Norway	Department of Ophthalmology, Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickness after 6 weeks	Measure central macular thickness (in um) on optical coherence tomography (OCT)	6 weeks after surgery
Primary	Cystoid macular edema (CME) after 6 weeks	Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)	6 weeks after surgery
Secondary	Intraocular inflammation	Measured by laser flare meter	Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Secondary	Visual outcome	Measure uncorrected and corrected distance visual acuity using visual acuity chart	Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Secondary	Intraocular pressure	Measured by tonometry	Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Secondary	Central macular thickness (CMT)	Measure CMT (in um) on optical coherence tomography (OCT)	Preoperatively, 1 week, and 6 months after surgery
Secondary	Cystoid macular edema (CME)	Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)	Preoperatively, 1 week, and 6 months after surgery