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Comparing postoperative recovery after vitrectomy using NSAID eyedrops versus steroid eyedrops
EU CTIS ID: 2024-518807-23-00
What this study is testing
To prove a reduced occurrence of post-operative increased intra-ocular pressure when using NSAID drops instead of steroid drops after vitrectomy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients over 18 years of age planned for vitrectomy for macular surgery (macular pucker, vitreomacular traction, macular hole) with/without phaco-emulsification
- Female participants must be either postmenopausal (no menses for ≥12 consecutive months without alternative medical cause) or surgically sterile (e.g., bilateral oophorectomy or hysterectomy).
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
You likely can't join if
- Participant has a history of other retinal disease that may affect the formation of macular edema
- Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
- Ocular hypertension (IOP > 21 mmHg) and/or glaucoma
- Systemic steroid or NSAID or immunosuppressant use
- Recent intra-ocular surgery (phaco-emulsification) < 6 months
- Previous vitrectomy surgery in study eye
See the full eligibility criteria
- Patients over 18 years of age planned for vitrectomy for macular surgery (macular pucker, vitreomacular traction, macular hole) with/without phaco-emulsification
- Female participants must be either postmenopausal (no menses for ≥12 consecutive months without alternative medical cause) or surgically sterile (e.g., bilateral oophorectomy or hysterectomy).
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Participant has a history of other retinal disease that may affect the formation of macular edema
- Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
- Ocular hypertension (IOP > 21 mmHg) and/or glaucoma
- Systemic steroid or NSAID or immunosuppressant use
- Recent intra-ocular surgery (phaco-emulsification) < 6 months
- Previous vitrectomy surgery in study eye
- Women of childbearing potential , defined as sexually mature females who have not undergone sterilization or are not postmenopausal as per above definition.
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Hypersensitivity towards diclofenac and one of the excipients of the finished product
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.