Cataract SurgeryPhase 4pre-CINNCT05331690
Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)
A Phase 4 study testing Nepafenac Ophthalmic and Dexamethasone Ophthalmic in people with Cataract Surgery, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Nepafenac Ophthalmic and Dexamethasone Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 25 Nov 2022to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Oslo University Hospital
Oslo
Olav Kristianslund, PhD
About this study
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).
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.
- Conditions
- Cataract Surgery
- Being tested
- Nepafenac Ophthalmic, Dexamethasone Ophthalmic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac OphthalmicDrug
Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery
Nepafenac OphthalmicDrug
Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery
Dexamethasone OphthalmicDrug
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 NSAIDs pre | Active comparator | Topical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery Receives: Drug: Nepafenac Ophthalmic |
| Group 2 NSAIDs post | Active comparator | Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery Receives: Drug: Nepafenac Ophthalmic |
| Group 3 NSAIDs and steroids | Active comparator | Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery Receives: Drug: Nepafenac Ophthalmic; Drug: Dexamethasone Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central macular thickness after 6 weeks
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Measured: 6 weeks after surgery
Cystoid macular edema (CME) after 6 weeks
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Measured: 6 weeks after surgery
Secondary outcomes (5)
Intraocular inflammation
Measured by laser flare meter
Measured: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Measured: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Intraocular pressure
Measured by tonometry
Measured: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Central macular thickness (CMT)
Measure CMT (in um) on optical coherence tomography (OCT)
Measured: Preoperatively, 1 week, and 6 months after surgery
Cystoid macular edema (CME)
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Measured: Preoperatively, 1 week, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start25 Nov 2022
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olav Kristianslund, Oslo University Hospital
- Investigators
- Olav Kristianslund, MD PhD, Principal investigator, Department of Ophthalmology, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331690
- Sponsor's protocol ID
- 93944
- Other IDs
- 2020-003407-34
- Acronym
- pre-CIN
- Status last verified
- Nov 2022
- First submitted
- 9 Apr 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05331690
- Acronym / sponsor ID
- pre-CIN / 93944
- Conditions
- Cataract Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 NSAIDs pre | Active comparator | Drug: Nepafenac OphthalmicTopical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery |
| Group 2 NSAIDs post | Active comparator | Drug: Nepafenac OphthalmicTopical nepafenac (Nevanac) 3 mg/ml started the day after surgery |
| Group 3 NSAIDs and steroids | Active comparator | Drug: Nepafenac Ophthalmic, Drug: Dexamethasone OphthalmicTopical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nepafenac OphthalmicTopical nepafenac (Nevanac) 3 mg/ml starter the day before surgery | Drug | Group 1 NSAIDs pre |
| Nepafenac OphthalmicTopical nepafenac (Nevanac) 3 mg/ml started the day after surgery | Drug | Group 2 NSAIDs post, Group 3 NSAIDs and steroids |
| Dexamethasone OphthalmicTopical dexamethasone 1 mg/ml (Spersadex) started the day after surgery | Drug | Group 3 NSAIDs and steroids |
Primary outcome
Central macular thickness after 6 weeks
Time frame: 6 weeks after surgery
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 6 weeks
Time frame: 6 weeks after surgery
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
5 secondary outcomes
Intraocular inflammation
Time frame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Visual outcome
Time frame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Intraocular pressure
Time frame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Central macular thickness (CMT)
Time frame: Preoperatively, 1 week, and 6 months after surgery
Cystoid macular edema (CME)
Time frame: Preoperatively, 1 week, and 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav Kristianslund, MD PhD principal investigator
Department of Ophthalmology, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nepafenac Ophthalmic and Dexamethasone Ophthalmic in people with Cataract Surgery, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olav Kristianslund, MD PhD (+4722118545, olakri@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central macular thickness after 6 weeks (time frame: 6 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.