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DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC) (DMEC)

Primary Purpose

Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), Descemet Membrane Endothelial Keratoplasty (DMEK)

Status
Recruiting
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
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 Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

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 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • Department of Ophthalmology, Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control (dexamethasone only)

Study group (NSAIDs and dexamethasone)

Arm Description

Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery

Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.

Outcomes

Primary Outcome Measures

Central macular thickness after 4 weeks
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 4 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
Intraocular pressure
Measured by tonometry
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Corneal endothelial status
Measure corneal endothelial cell density using microscopy instrument
Patient reported outcome measure (PROM)
COMToL questionnaire for ocular medication
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
September 24, 2021
Last Updated
November 26, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05072262
Brief Title
DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
Acronym
DMEC
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)
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
June 2024 (Anticipated)
Study Completion Date
October 2026 (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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), Descemet Membrane Endothelial Keratoplasty (DMEK)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control (dexamethasone only)
Arm Type
Active Comparator
Arm Description
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery
Arm Title
Study group (NSAIDs and dexamethasone)
Arm Type
Experimental
Arm Description
Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.
Intervention Type
Drug
Intervention Name(s)
Nepafenac Ophthalmic
Intervention Description
Topical nepafenac (Nevanac) 3 mg/ml
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Ophthalmic
Intervention Description
Topical dexamethasone 1 mg/ml (Spersadex)
Primary Outcome Measure Information:
Title
Central macular thickness after 4 weeks
Description
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Time Frame
4 weeks after surgery
Title
Cystoid macular edema (CME) after 4 weeks
Description
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Time Frame
4 weeks after surgery
Secondary Outcome Measure Information:
Title
Intraocular inflammation
Description
Measured by laser flare meter
Time Frame
Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
Title
Intraocular pressure
Description
Measured by tonometry
Time Frame
Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery
Title
Visual outcome
Description
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Time Frame
Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery
Title
Corneal endothelial status
Description
Measure corneal endothelial cell density using microscopy instrument
Time Frame
1 week, 4 weeks, 2 months and 2 years after surgery
Title
Patient reported outcome measure (PROM)
Description
COMToL questionnaire for ocular medication
Time Frame
1 week, 4 weeks and 2 months after surgery
Title
Central macular thickness (CMT)
Description
Measure CMT (in um) on optical coherence tomography (OCT)
Time Frame
Preoperatively, and 1 week, 2 months, and 2 years 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, and 1 week, 2 months, and 2 years 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 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. Exclusion Criteria: 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)
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

Learn more about this trial

DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)

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