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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05331690
Other study ID # 93944
Secondary ID 2020-003407-34
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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