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

Sponsor
Oslo University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05331690
Collaborator
(none)
500
Enrollment
3
Arms
19
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nepafenac Ophthalmic
  • Drug: Nepafenac Ophthalmic
  • Drug: Dexamethasone Ophthalmic
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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).
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1 NSAIDs pre

Topical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery

Drug: Nepafenac Ophthalmic
Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery
Active Comparator: Group 2 NSAIDs post

Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery

Drug: Nepafenac Ophthalmic
Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery
Active Comparator: Group 3 NSAIDs and steroids

Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery

Drug: Nepafenac Ophthalmic
Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery

Drug: Dexamethasone Ophthalmic
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery

Outcome Measures

Primary Outcome Measures

  1. Central macular thickness after 6 weeks [6 weeks after surgery]

    Measure central macular thickness (in um) on optical coherence tomography (OCT)

  2. Cystoid macular edema (CME) after 6 weeks [6 weeks after surgery]

    Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)

Secondary Outcome Measures

  1. Intraocular inflammation [Preoperatively, and 1 week, 6 weeks, 6 months after surgery]

    Measured by laser flare meter

  2. Visual outcome [Preoperatively, and 1 week, 6 weeks, 6 months after surgery]

    Measure uncorrected and corrected distance visual acuity using visual acuity chart

  3. Intraocular pressure [Preoperatively, and 1 week, 6 weeks, 6 months after surgery]

    Measured by tonometry

  4. Central macular thickness (CMT) [Preoperatively, 1 week, and 6 months after surgery]

    Measure CMT (in um) on optical coherence tomography (OCT)

  5. Cystoid macular edema (CME) [Preoperatively, 1 week, and 6 months after surgery]

    Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oslo University Hospital

Investigators

  • Principal Investigator: Olav Kristianslund, MD PhD, Department of Ophthalmology, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olav Kristianslund, Principal investigator, Head of section / Senior consultant MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT05331690
Other Study ID Numbers:
  • 93944
  • 2020-003407-34
First Posted:
Apr 18, 2022
Last Update Posted:
Apr 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract
Inflammation
Dexamethasone
Nepafenac

Study Results

No Results Posted as of Apr 18, 2022