Pseudophakic Bullous KeratopathyNCT04344522
Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery
A study testing Descemet membrane endothelial keratoplasty DMEK, IOL exchange and iridoplasty in people with Pseudophakic Bullous Keratopathy and Anterior Chamber Intraocular Lens, run by Alexandria University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudophakic Bullous Keratopathy, Anterior Chamber Intraocular Lens
- What is being tested?
- Descemet membrane endothelial keratoplasty DMEK, IOL exchange and iridoplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2020to 1 Nov 2021
- Phase
- Interventional
- 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 having pseudophakic bullous keratopathy associated with an anterior chamber intraocular lens.
- Age above 18 years old.
Who cannot join
- Patients with corneal stromal scarring .
- Patients who had prior glaucoma drainage devices implantation. 3 Patient with non-repairable loss in the iris tissue.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Alexandria, 21111
Mohamed M Kolaib, MBBCh, 00201283674800, mohamedkolaib@hotmail.com
Mohamed B Goweida, MD, 00201011755557, mbahgat@yahoo.com
About this study
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
Read the detailed description
Pseudophakic Bullous keratopathy is the second leading indication for endothelial keratoplasty. One of the main controversies in the management of PBK in the presence of an AC IOl is whether to retain the IOL or perform an IOL exchange with a PC IOL. The investigators believe that retention of an AC IOL can be hazardous to the DMEK graft due to reduced depth of the anterior chamber and traumatic touch between the graft and the IOL during graft unfolding and even postoperatively. On the other hand , performing an IOL exchange is relatively time consuming and requires excess manipulation of the iris tissue with the risk of intraoperative hyphema and postoperative inflammation which can affect the endothelial graft survival and cell count.
Aim of the study : to compare the outcome and complications between performing intraocular lens (IOL) exchange and Descemet membrane endothelial keratoplasty (DMEK) as single stage versus two stage procedure in the management of pseudophakic bullous keratopathy associated with anterior chamber IOL.
Methods :
The study will be a prospective randomized controlled trial. Eligible subjects with pseudophakic bullous keratopathy and AC IOL will be assigned into two groups each comprising 10 eyes. One group will undergo AC IOL exchange with posterior chamber (PC) IOL ( Poly methyl methacrylate (PMMA) lens or iris claw lens if there is no adequate capsular support) combined with DMEK in the same setting. The other group will undergo 2 stage procedure ; first one is IOL exchange , iridoplasty (if required) and inferior peripheral iridectomy and the second stage is DMEK one month later.
- Being tested
- Descemet membrane endothelial keratoplasty DMEK, IOL exchange, iridoplasty, Inferior peripheral iridectomy
- Keywords
- Descemet membrane endothelial keratoplasty DMEK, Anterior chamber intraocular lens AC IOL, pseudophakic bullous keratopathy PBK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descemet membrane endothelial keratoplasty DMEKProcedure or surgery
DMEK : it involves separating the Descemet membrane from a corneal donor graft , doing a descematorhexis in the recepient cornea , loading and injection of the graft into the anterior chamber , unfolding and fixing the graft to the recepient cornea by intracameral air bubble.
IOL exchangeProcedure or surgery
IOL exchange : it involves performing a corneoscleral tunnel , freeing the AC IOL from any adhesions and explanting it through the tunnel , then implanting a posterior chamber PMMA lens or iris claw lens if there is no adequate capsular support.
iridoplastyProcedure or surgery
iridoplasty : repairing any iris defect by using 10/0 prolene.
Inferior peripheral iridectomyProcedure or surgery
Inferior peripheral iridectomy : performed by vannus scissor to avoid postoperative pupillary block due to the intracameral air .
| Study group | Role | What they receive |
|---|---|---|
| sequential 2 stage procedure | Experimental | In this arm , the procedure will be performed in two stages ; the first stage will include performing IOL exchange together with iridoplasty ( if required) and inferior peripheral iridectomy (PI) and the second stage is performing DMEK one month later Receives: Procedure: Descemet membrane endothelial keratoplasty DMEK; Procedure: IOL exchange; Procedure: iridoplasty; Procedure: Inferior peripheral iridectomy |
| combined single stage procedure | Experimental | In this arm, both IOL exchange and DMEK will be performed in the same setting Receives: Procedure: Descemet membrane endothelial keratoplasty DMEK; Procedure: IOL exchange; Procedure: iridoplasty; Procedure: Inferior peripheral iridectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative endothelial cell loss in percentage
The postoperative endothelial cell count will be determined in cell/mm2 using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA) at 3 months and compared to the preoperative endothelial cell count of the donor graft to calculate the percentage of endothelial cell loss
Measured: 3 months
Best spectacle corrected visual acuity
best spectacle corrected visual acuity using the decimal system
Measured: 3 months
postoperative hyphema and and intraocular pressure spikes
Any postoperative hyphema and anterior chamber inflammatory reactions will determined by slit lamp examination:
Hyphema if found will be graded into :
- Microscopic hyphema : circulating red blood cells in the AC
- Grade I : less than one third the AC
- Grade II: one third to one half the AC
- Grade III: more than one half the AC but not total
- Grade IV : total hyphema. and intraocular pressure spikes will detected using the Goldmann applanation tonometer to measure the intraocular pressure in mmHg
Measured: 1month postoperatively
Postoperative AC inflammatory reactions
postoperative AC inflammatory reactions including cell and flare will be determined by slit lamp examination under high magnification:
AC cells will be graded according to the Standardization of Uveitis Nomenclature (SUN) group grading system as following :
Grade 0 : 5 or less cells in 1*1mm slit beam Grade 1 : 6- 15 cells in 1*1mm slit beam Grade II : 16-25 cells in 1*1mm slit beam Grade III : 26-50 cells in 1*1mm slit beam grade IV : more than 50 cells in 1*1mm slit beam .
AC flare will be graded according to the SUN grading system :
Grade 0 : none Grade I : faint Grade II : moderate ( iris and lens details still seen ) Grade III : Marked ( iris and lens details hazy) Grade IV : intense ( fixed and plastic aqueous ).
Measured: 1 month postoperatively
Postoperative intraocular pressure spikes
postoperative intracular pressure will be measured by Goldmann Applanation Tonometer in mmHg
Measured: 1 month postoperatively
Secondary outcomes (4)
Keratometric values
Keratometric values will be determined in Diopters using Autorefractometer/Keratometer , the difference between the steep and flat keratometric values will determine the corneal astigamtism in diopters
Measured: 3 months
central corneal thickness
central corneal thickness will be determined in micrometer using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA)
Measured: 3 months postoperatively
graft detachment
The occurrence of postoperative graft detachment will be determined by slit lamp examination . The incidence of graft detachment will be determined in each group .
Measured: 1 week postoperatively
Spherical equivalent
spherical equivalent will be determined using the autorefractometer in diopters
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start11 Aug 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pseudophakic Bullous KeratopathyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kolaib, Alexandria University
- Investigators
- Mohamed M Kolaib, MBBCh, Principal investigator, Alexandria Faculty of MedicineMohamed B Goweida, MD, Study chair, Alexandria Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344522
- Sponsor's protocol ID
- DMEK ACIOL
- Status last verified
- Aug 2020
- First submitted
- 3 Apr 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melles GR, Ong TS, Ververs B, van der Wees J. Preliminary clinical results of Descemet membrane endothelial keratoplasty. Am J Ophthalmol. 2008 Feb;145(2):222-227. doi: 10.1016/j.ajo.2007.09.021. Epub 2007 Dec 3.
PubMed 18061137Ham L, Dapena I, van Luijk C, van der Wees J, Melles GR. Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50 consecutive cases. Eye (Lond). 2009 Oct;23(10):1990-8. doi: 10.1038/eye.2008.393. Epub 2009 Jan 30.
PubMed 19182768Dapena I, Ham L, Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol. 2009 Jul;20(4):299-307. doi: 10.1097/ICU.0b013e32832b8d18.
PubMed 19417653Woo JH, Ang M, Htoon HM, Tan D. Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty and Penetrating Keratoplasty. Am J Ophthalmol. 2019 Nov;207:288-303. doi: 10.1016/j.ajo.2019.06.012. Epub 2019 Jun 19.
PubMed 31228467Pricopie S, Istrate S, Voinea L, Leasu C, Paun V, Radu C. Pseudophakic bullous keratopathy. Rom J Ophthalmol. 2017 Apr-Jun;61(2):90-94. doi: 10.22336/rjo.2017.17.
PubMed 29450379Ravalico G, Botteri E, Baccara F. Long-term endothelial changes after implantation of anterior chamber intraocular lenses in cataract surgery. J Cataract Refract Surg. 2003 Oct;29(10):1918-23. doi: 10.1016/s0886-3350(02)02052-7.
PubMed 14604711Liarakos VS, Ham L, Dapena I, Tong CM, Quilendrino R, Yeh RY, Melles GR. Endothelial keratoplasty for bullous keratopathy in eyes with an anterior chamber intraocular lens. J Cataract Refract Surg. 2013 Dec;39(12):1835-45. doi: 10.1016/j.jcrs.2013.05.045.
PubMed 24286840Gupta PK, Bordelon A, Vroman DT, Afshari NA, Kim T. Early outcomes of descemet stripping automated endothelial keratoplasty in pseudophakic eyes with anterior chamber intraocular lenses. Am J Ophthalmol. 2011 Jan;151(1):24-28.e1. doi: 10.1016/j.ajo.2010.07.003. Epub 2010 Oct 20.
PubMed 20970110
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descemet Membrane Endothelial Keratoplasty Combined With Intraocular Lens Exchange: Sequential Versus Combined Surgery
- ClinicalTrials.gov ID
- NCT04344522
- Acronym / sponsor ID
- DMEK ACIOL
- Keywords
- Descemet membrane endothelial keratoplasty DMEK, Anterior chamber intraocular lens AC IOL, pseudophakic bullous keratopathy PBK
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 14 Apr 2020 (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.
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
Detailed description
Pseudophakic Bullous keratopathy is the second leading indication for endothelial keratoplasty. One of the main controversies in the management of PBK in the presence of an AC IOl is whether to retain the IOL or perform an IOL exchange with a PC IOL. The investigators believe that retention of an AC IOL can be hazardous to the DMEK graft due to reduced depth of the anterior chamber and traumatic touch between the graft and the IOL during graft unfolding and even postoperatively. On the other hand , performing an IOL exchange is relatively time consuming and requires excess manipulation of the iris tissue with the risk of intraoperative hyphema and postoperative inflammation which can affect the endothelial graft survival and cell count.
Aim of the study : to compare the outcome and complications between performing intraocular lens (IOL) exchange and Descemet membrane endothelial keratoplasty (DMEK) as single stage versus two stage procedure in the management of pseudophakic bullous keratopathy associated with anterior chamber IOL.
Methods :
The study will be a prospective randomized controlled trial. Eligible subjects with pseudophakic bullous keratopathy and AC IOL will be assigned into two groups each comprising 10 eyes. One group will undergo AC IOL exchange with posterior chamber (PC) IOL ( Poly methyl methacrylate (PMMA) lens or iris claw lens if there is no adequate capsular support) combined with DMEK in the same setting. The other group will undergo 2 stage procedure ; first one is IOL exchange , iridoplasty (if required) and inferior peripheral iridectomy and the second stage is DMEK one month later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| sequential 2 stage procedure | Experimental | Procedure: Descemet membrane endothelial keratoplasty DMEK, Procedure: IOL exchange, Procedure: iridoplasty, Procedure: Inferior peripheral iridectomyIn this arm , the procedure will be performed in two stages ; the first stage will include performing IOL exchange together with iridoplasty ( if required) and inferior peripheral iridectomy (PI) and the second stage is performing DMEK one month later |
| combined single stage procedure | Experimental | Procedure: Descemet membrane endothelial keratoplasty DMEK, Procedure: IOL exchange, Procedure: iridoplasty, Procedure: Inferior peripheral iridectomyIn this arm, both IOL exchange and DMEK will be performed in the same setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients having pseudophakic bullous keratopathy associated with an anterior chamber intraocular lens.
- Age above 18 years old.
Key exclusion criteria (2 listed)
- Patients with corneal stromal scarring .
- Patients who had prior glaucoma drainage devices implantation. 3 Patient with non-repairable loss in the iris tissue.
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 |
|---|---|---|
| Descemet membrane endothelial keratoplasty DMEKDMEK : it involves separating the Descemet membrane from a corneal donor graft , doing a descematorhexis in the recepient cornea , loading and injection of the graft into the anterior chamber , unfolding and fixing the graft to the recepient cornea by intracameral air bubble. | Procedure or surgery | combined single stage procedure, sequential 2 stage procedure |
| IOL exchangeIOL exchange : it involves performing a corneoscleral tunnel , freeing the AC IOL from any adhesions and explanting it through the tunnel , then implanting a posterior chamber PMMA lens or iris claw lens if there is no adequate capsular support. | Procedure or surgery | combined single stage procedure, sequential 2 stage procedure |
| iridoplastyiridoplasty : repairing any iris defect by using 10/0 prolene. | Procedure or surgery | combined single stage procedure, sequential 2 stage procedure |
| Inferior peripheral iridectomyInferior peripheral iridectomy : performed by vannus scissor to avoid postoperative pupillary block due to the intracameral air . | Procedure or surgery | combined single stage procedure, sequential 2 stage procedure |
Primary outcome
postoperative endothelial cell loss in percentage
Time frame: 3 months
The postoperative endothelial cell count will be determined in cell/mm2 using the Konan Cellchek specular microscope (Konan Medical , Irvine, California , USA) at 3 months and compared to the preoperative endothelial cell count of the donor graft to calculate the percentage of endothelial cell loss
Best spectacle corrected visual acuity
Time frame: 3 months
best spectacle corrected visual acuity using the decimal system
postoperative hyphema and and intraocular pressure spikes
Time frame: 1month postoperatively
Any postoperative hyphema and anterior chamber inflammatory reactions will determined by slit lamp examination: Hyphema if found will be graded into : 1. Microscopic hyphema : circulating red blood cells in the AC 2. Grade I : less than one third the AC 3. Grade II: one third to one half the AC 4. Grade III: more than one half the AC but not total 5. Grade IV : total hyphema. and intraocular pressure spikes will detected using the Goldmann applanation tonometer to measure the intraocular pressure in mmHg
Postoperative AC inflammatory reactions
Time frame: 1 month postoperatively
postoperative AC inflammatory reactions including cell and flare will be determined by slit lamp examination under high magnification: AC cells will be graded according to the Standardization of Uveitis Nomenclature (SUN) group grading system as following : Grade 0 : 5 or less cells in 1*1mm slit beam Grade 1 : 6- 15 cells in 1*1mm slit beam Grade II : 16-25 cells in 1*1mm slit beam Grade III : 26-50 cells in 1*1mm slit beam grade IV : more than 50 cells in 1*1mm slit beam . AC flare will be graded according to the SUN grading system : Grade 0 : none Grade I : faint Grade II : moderate ( iris and lens details still seen ) Grade III : Marked ( iris and lens details hazy) Grade IV : intense ( fixed and plastic aqueous ).
Postoperative intraocular pressure spikes
Time frame: 1 month postoperatively
postoperative intracular pressure will be measured by Goldmann Applanation Tonometer in mmHg
4 secondary outcomes
Keratometric values
Time frame: 3 months
central corneal thickness
Time frame: 3 months postoperatively
graft detachment
Time frame: 1 week postoperatively
Spherical equivalent
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Background: PubMed 18061137Melles GR, Ong TS, Ververs B, van der Wees J. Preliminary clinical results of Descemet membrane endothelial keratoplasty. Am J Ophthalmol. 2008 Feb;145(2):222-227. doi: 10.1016/j.ajo.2007.09.021. Epub 2007 Dec 3.
- Background: PubMed 19182768Ham L, Dapena I, van Luijk C, van der Wees J, Melles GR. Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50 consecutive cases. Eye (Lond). 2009 Oct;23(10):1990-8. doi: 10.1038/eye.2008.393. Epub 2009 Jan 30.
- Background: PubMed 19417653Dapena I, Ham L, Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol. 2009 Jul;20(4):299-307. doi: 10.1097/ICU.0b013e32832b8d18.
- Background: PubMed 31228467Woo JH, Ang M, Htoon HM, Tan D. Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty and Penetrating Keratoplasty. Am J Ophthalmol. 2019 Nov;207:288-303. doi: 10.1016/j.ajo.2019.06.012. Epub 2019 Jun 19.
- Background: PubMed 29450379Pricopie S, Istrate S, Voinea L, Leasu C, Paun V, Radu C. Pseudophakic bullous keratopathy. Rom J Ophthalmol. 2017 Apr-Jun;61(2):90-94. doi: 10.22336/rjo.2017.17.
- Background: PubMed 14604711Ravalico G, Botteri E, Baccara F. Long-term endothelial changes after implantation of anterior chamber intraocular lenses in cataract surgery. J Cataract Refract Surg. 2003 Oct;29(10):1918-23. doi: 10.1016/s0886-3350(02)02052-7.
- Background: PubMed 24286840Liarakos VS, Ham L, Dapena I, Tong CM, Quilendrino R, Yeh RY, Melles GR. Endothelial keratoplasty for bullous keratopathy in eyes with an anterior chamber intraocular lens. J Cataract Refract Surg. 2013 Dec;39(12):1835-45. doi: 10.1016/j.jcrs.2013.05.045.
- Background: PubMed 20970110Gupta PK, Bordelon A, Vroman DT, Afshari NA, Kim T. Early outcomes of descemet stripping automated endothelial keratoplasty in pseudophakic eyes with anterior chamber intraocular lenses. Am J Ophthalmol. 2011 Jan;151(1):24-28.e1. doi: 10.1016/j.ajo.2010.07.003. Epub 2010 Oct 20.
- Individual participant dataSharing planned: No
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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.
Mohamed M Kolaib, MBBCh principal investigator
Alexandria Faculty of Medicine
Mohamed B Goweida, MD study chair
Alexandria Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descemet membrane endothelial keratoplasty DMEK, IOL exchange and iridoplasty in people with Pseudophakic Bullous Keratopathy and Anterior Chamber Intraocular Lens, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 2 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 12 Aug 2020. 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 Egypt. 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.
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 Mohamed M Kolaib, MBBCh (00201283674800, mohamedkolaib@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative endothelial cell loss in percentage (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344522, which also lists 8 linked publications.
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 12 Aug 2020.