UnknownNot Applicable

Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery

Egypt20 participantsStarted 2020-08-11

Plain-language summary

Surgical treatment of corneal endothelial decompensation in the presence of an anterior chamber intraocular lens (AC IOL) is technically challenging. The ultimate management is to perform Descemet membrane endothelial keratoplasty (DMEK). However , unfolding the DMEK graft in the presence of an AC IOL can be difficult and injurious to the graft so the investigators recommend exchanging the AC IOL with a posterior chamber IOL first. In this study , the investigators aim to compare the outcome and complications of performing DMEK and IOL exchange as combined one stage surgery versus .sequential 2 stage procedure

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients having pseudophakic bullous keratopathy associated with an anterior chamber intraocular lens.
. Age above 18 years old.

Exclusion criteria

. Patients with corneal stromal scarring .
. Patients who had prior glaucoma drainage devices implantation. 3 Patient with non-repairable loss in the iris tissue.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

postoperative endothelial cell loss in percentage

Timeframe: 3 months

Best spectacle corrected visual acuity

Timeframe: 3 months

postoperative hyphema and and intraocular pressure spikes

Timeframe: 1month postoperatively

Postoperative AC inflammatory reactions

Timeframe: 1 month postoperatively

Postoperative intraocular pressure spikes

Timeframe: 1 month postoperatively

Trial details

NCT IDNCT04344522

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-01

Contact for this trial

Mohamed M Kolaib, MBBCh

00201283674800 mohamedkolaib@hotmail.com

View on ClinicalTrials.gov More Pseudophakic Bullous Keratopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients having pseudophakic bullous keratopathy associated with an anterior chamber intraocular lens.
. Age above 18 years old.

Exclusion criteria

. Patients with corneal stromal scarring .
. Patients who had prior glaucoma drainage devices implantation. 3 Patient with non-repairable loss in the iris tissue.

What they're measuring

postoperative endothelial cell loss in percentage

Timeframe: 3 months

Best spectacle corrected visual acuity

Timeframe: 3 months

postoperative hyphema and and intraocular pressure spikes

Timeframe: 1month postoperatively

Postoperative AC inflammatory reactions

Timeframe: 1 month postoperatively

Postoperative intraocular pressure spikes

Timeframe: 1 month postoperatively