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

Primary Purpose

Cataract Surgery

Status
Recruiting
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Nepafenac Ophthalmic
Nepafenac Ophthalmic
Dexamethasone Ophthalmic
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Ophthalmology, Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1 NSAIDs pre

Group 2 NSAIDs post

Group 3 NSAIDs and steroids

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Central macular thickness after 6 weeks
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 6 weeks
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)

Secondary Outcome Measures

Intraocular inflammation
Measured by laser flare meter
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Intraocular pressure
Measured by tonometry
Central macular thickness (CMT)
Measure CMT (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME)
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)

Full Information

First Posted
April 9, 2022
Last Updated
November 26, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05331690
Brief Title
Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)
Acronym
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).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 NSAIDs pre
Arm Type
Active Comparator
Arm Description
Topical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery
Arm Title
Group 2 NSAIDs post
Arm Type
Active Comparator
Arm Description
Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery
Arm Title
Group 3 NSAIDs and steroids
Arm Type
Active Comparator
Arm Description
Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery
Intervention Type
Drug
Intervention Name(s)
Nepafenac Ophthalmic
Intervention Description
Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery
Intervention Type
Drug
Intervention Name(s)
Nepafenac Ophthalmic
Intervention Description
Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Ophthalmic
Intervention Description
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery
Primary Outcome Measure Information:
Title
Central macular thickness after 6 weeks
Description
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Time Frame
6 weeks after surgery
Title
Cystoid macular edema (CME) after 6 weeks
Description
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Time Frame
6 weeks after surgery
Secondary Outcome Measure Information:
Title
Intraocular inflammation
Description
Measured by laser flare meter
Time Frame
Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Title
Visual outcome
Description
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Time Frame
Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Title
Intraocular pressure
Description
Measured by tonometry
Time Frame
Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Title
Central macular thickness (CMT)
Description
Measure CMT (in um) on optical coherence tomography (OCT)
Time Frame
Preoperatively, 1 week, and 6 months after surgery
Title
Cystoid macular edema (CME)
Description
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Time Frame
Preoperatively, 1 week, and 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olav Kristianslund, MD PhD
Phone
+4722118545
Email
olakri@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Kristianslund, MD PhD
Organizational Affiliation
Department of Ophthalmology, Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olav Kristianslund, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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