Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)Phase 4DMECNCT05072262
DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
A Phase 4 study testing Nepafenac Ophthalmic and Dexamethasone Ophthalmic in people with Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK), run by Oslo University Hospital at 1 site in Norway.
Trial summary
The DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), Descemet Membrane Endothelial Keratoplasty (DMEK)
- What is being tested?
- Nepafenac Ophthalmic and Dexamethasone Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 25 Nov 2022to Oct 2026
- 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 DSAEK or DMEK
- 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 or possible pregnancy during the study period
- Preoperative macular edema and/or ongoing treatment for macular edema
- Re-transplantation
- In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
- Aphakic eyes (eyes without a biological or artificial intraocular lens)
- Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)
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 Two-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Postoperative Topical NSAIDs and Steroids to Only Postoperative Topical Steroids in Patients Undergoing Corneal Endothelial Transplantations (DMEC)
The DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK).
- Conditions
- Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), Descemet Membrane Endothelial Keratoplasty (DMEK)
- 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
Dexamethasone OphthalmicDrug
Topical dexamethasone 1 mg/ml (Spersadex)
| Study group | Role | What they receive |
|---|---|---|
| Control (dexamethasone only) | Active comparator | Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery Receives: Drug: Dexamethasone Ophthalmic |
| Study group (NSAIDs and dexamethasone) | Experimental | Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (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 4 weeks
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Measured: 4 weeks after surgery
Cystoid macular edema (CME) after 4 weeks
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Measured: 4 weeks after surgery
Secondary outcomes (7)
Intraocular inflammation
Measured by laser flare meter
Measured: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
Intraocular pressure
Measured by tonometry
Measured: Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Measured: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
Corneal endothelial status
Measure corneal endothelial cell density using microscopy instrument
Measured: 1 week, 4 weeks, 2 months and 2 years after surgery
Patient reported outcome measure (PROM)
COMToL questionnaire for ocular medication
Measured: 1 week, 4 weeks and 2 months after surgery
Central macular thickness (CMT)
Measure CMT (in um) on optical coherence tomography (OCT)
Measured: Preoperatively, and 1 week, 2 months, and 2 years 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, and 1 week, 2 months, and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start25 Nov 2022
- Primary completionJun 2024 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)Studies 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
- 300 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
- NCT05072262
- Sponsor's protocol ID
- 131128
- Other IDs
- 2020-003408-15
- Acronym
- DMEC
- Status last verified
- Nov 2022
- First submitted
- 24 Sep 2021
- 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 Two-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Postoperative Topical NSAIDs and Steroids to Only Postoperative Topical Steroids in Patients Undergoing Corneal Endothelial Transplantations (DMEC)
- ClinicalTrials.gov ID
- NCT05072262
- Acronym / sponsor ID
- DMEC / 131128
- Conditions
- Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), Descemet Membrane Endothelial Keratoplasty (DMEK)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Oct 2021 (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 DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (dexamethasone only) | Active comparator | Drug: Dexamethasone OphthalmicTopical dexamethasone 1 mg/ml (Spersadex) started the day after surgery |
| Study group (NSAIDs and dexamethasone) | Experimental | Drug: Nepafenac Ophthalmic, Drug: Dexamethasone OphthalmicTopical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (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 (4 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 DSAEK or DMEK
- 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 (7 listed)
- Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
- Pregnancy or possible pregnancy during the study period
- Preoperative macular edema and/or ongoing treatment for macular edema
- Re-transplantation
- In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
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 | Drug | Study group (NSAIDs and dexamethasone) |
| Dexamethasone OphthalmicTopical dexamethasone 1 mg/ml (Spersadex) | Drug | Control (dexamethasone only), Study group (NSAIDs and dexamethasone) |
Primary outcome
Central macular thickness after 4 weeks
Time frame: 4 weeks after surgery
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 4 weeks
Time frame: 4 weeks after surgery
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
7 secondary outcomes
Intraocular inflammation
Time frame: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
Intraocular pressure
Time frame: Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery
Visual outcome
Time frame: Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
Corneal endothelial status
Time frame: 1 week, 4 weeks, 2 months and 2 years after surgery
Patient reported outcome measure (PROM)
Time frame: 1 week, 4 weeks and 2 months after surgery
Central macular thickness (CMT)
Time frame: Preoperatively, and 1 week, 2 months, and 2 years after surgery
Cystoid macular edema (CME)
Time frame: Preoperatively, and 1 week, 2 months, and 2 years 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
Related trials for Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
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 Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK), 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 4 inclusion and 7 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 4 weeks (time frame: 4 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.