Corneal TransplantationKPro-HP-EndoNCT04337944
Endoscopic Assisted Anterior Hyaloid Peeling in Boston Type 1 Keratoprosthesis (KPro-HP-Endo)
A study testing Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy in people with Corneal Transplantation and Glaucoma and Ocular Hypertension, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Common complications of the Boston keratoprosthesis type 1 (KPro) surgery include retroprosthetic membrane formation, glaucoma, and retinal detachment. Often pars plana vitrectomy (PPV) is performed at the same time as KPro surgery for different indications. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Transplantation, Glaucoma and Ocular Hypertension, Postoperative Complications
- What is being tested?
- Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2020to Mar 2025
- Phase
- Interventional
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged from 18 to 80 years old
- Informed consent
- Boston keratoprosthesis candidate
- Pars plana vitrectomy candidate
- Ability to be followed for the duration of the study
Who cannot join
- Aged less than 18 or more than 80 years old
- Inability to give informed consent
- Repeat Boston keratoprosthesis
- Repeat pars plana vitrectomy
Trial locations and contacts
1 site in 1 country.
Marie-Catherine Tessier, M.Sc. contact
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Marie-Catherine Tessier, M.Sc., 1-514-890-8000 ext. 11550, marie-catherine.tessier.chum@ssss.gouv.qc.ca
Mona Harissi-Dagher, MD
About this study
Official title: Impact of Endoscopic Assisted Anterior Hyaloid Peeling in Boston Type 1 Keratoprosthesis in Reducing Postoperative Complications
Common complications of the Boston keratoprosthesis type 1 (KPro) surgery include retroprosthetic membrane formation, glaucoma, and retinal detachment. Often pars plana vitrectomy (PPV) is performed at the same time as KPro surgery for different indications. It has been shown to reduce postoperative complications in comparison to when it is performed after the KPro surgery. Patients who receive a complete PPV with peeling of the anterior hyaloid membrane have a lower incidence of retroprosthetic membrane formation and less vision loss due to glaucoma when compared to patients with partial PPV or anterior vitrectomy. During a complete PPV, peeling of the anterior hyaloid membrane is a difficult step because visualisation is poor, but it can be improved using endoscopy. The investigators suggest that peeling of the anterior hyaloid membrane assisted by endoscopy during KPro surgery would decrease postoperative complications in comparison to a PPV done after KPro surgery and without endoscopy.
Read the detailed description
Boston keratoprosthesis type 1 (KPro) surgery is the most common corneal graft and is used to restore vision in patients with high risk of failure with traditional penetrating keratoplasty. Common complications of KPro surgery include retroprosthetic membrane formation behind the backplate of the KPro. Glaucoma is the most common threat to vision rehabilitation in patients with KPro. Glaucoma is often present before surgery and progresses after KPro, seven times faster than in patients with only glaucoma. Retinal detachment is a common posterior segment complication that arises post-KPro and can lead to a serious loss of vision. Pars plana vitrectomy (PPV) is the standard treatment for patients with vitreoretinal diseases and opacities. PPV can include peeling of the anterior hyaloid membrane to ensure total resection of the vitreous body. PPV allows for example for retroprosthetic membrane excision, installation or revision of a glaucoma drainage device, or repair of retinal detachment. Often PPV is performed at the same time as KPro surgery for different indications. It has been shown to reduce postoperative complications in comparison to when it is performed after the KPro surgery. Patients who receive a complete PPV with peeling of the anterior hyaloid membrane have a lower incidence of retroprosthetic membrane formation and less vision loss due to glaucoma when compared to patients with partial PPV or anterior vitrectomy. Combined surgeries of KPro and PPV offer a complete evaluation of the optic nerve and of the retina, which would not be possible otherwise. During a complete PPV, peeling of the anterior hyaloid membrane is a difficult step because visualisation is poor, especially with a KPro in place. Visualisation can be improved using endoscopy to visualize the inside of the eye over 360 degrees. The investigators suggest that peeling of the anterior hyaloid membrane assisted by endoscopy during KPro surgery would decrease postoperative complications in comparison to a PPV done after KPro surgery and without endoscopy.
- Conditions
- Corneal Transplantation, Glaucoma and Ocular Hypertension, Postoperative Complications, Vitrectomy, Endoscopy
- Being tested
- Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy
- Keywords
- Boston keratoprosthesis type 1, Pars plana vitrectomy, Endoscopy
- Medical subject headings
- Glaucoma, Ocular Hypertension, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopyProcedure or surgery
Patients will receive at the same time a Boston keratoprosthesis type 1 (KPro) with a pars plana vitrectomy (PPV) with anterior hyaloid membrane peeling assisted by endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with KPro, PPV, and endoscopy | Experimental | Patients will receive at the same time a Boston keratoprosthesis type 1 (KPro) with a pars plana vitrectomy (PPV) with anterior hyaloid membrane peeling assisted by endoscopy. Receives: Procedure: Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of retroprosthetic membrane formation
Rate of postoperative retroprosthetic membrane formation behind the backplate of the Boston keratoprosthesis. Retroprosthetic membrane formation is diagnosed by the investigator using an examination of the anterior chamber performed at the slit-lamp.
Measured: 12 months
Rate of retinal detachment
Rate of postoperative retinal detachment. Retinal detachment is diagnosed by the investigator using a dilated fundus (retinal) examination performed at the slit-lamp.
Measured: 12 months
Rate of glaucoma development
Rate of development or progression of glaucoma, determined based on intraocular pressure increase of > 21 mmHg, increase of glaucoma medications, optic nerve excavation progression, or need to undergo glaucoma filtration surgery.
Measured: 12 months
Secondary outcomes (8)
Proportion of patients with visual acuity better than 20/200
Proportion of patients with visual acuity better than 20/200 after surgery. The visual acuity is measured using the Snellen chart.
Measured: 12 months
Change of visual acuity
Change of visual acuity compared between before and after surgery. The visual acuity is measured using the Snellen chart.
Measured: 12 months
Time to retroprosthetic membrane formation after surgery
Time to retroprosthetic membrane formation, calculated in months from the time of the surgery. Retroprosthetic membrane formation behind the backplate of the Boston keratoprosthesis is diagnosed by the investigator using an examination of the anterior chamber performed at the slit-lamp.
Measured: 12 months
Time to retinal detachment after surgery
Time to retinal detachment, calculated in months from the time of the surgery. Retinal detachment is diagnosed by the investigator using a dilated fundus (retinal) examination performed at the slit-lamp.
Measured: 12 months
Proportion of participants requiring glaucoma surgery
Proportion of participants requiring glaucoma surgery (including glaucoma drainage device, trabeculectomy or cyclophotocoagulation) after the Boston keratoprothesis surgery.
Measured: 12 months
Proportion of patients with visual field loss of 30% or more
Proportion of patients with visual field loss of 30% or more, measured using the automated Humphrey 24-2 visual field. The loss of 30% or more of visual field is calculated using the first two postoperative tests as a reference.
Measured: 12 months
Proportion of patients with thinning of the nerve fiber layer
Proportion of patients with thinning of the nerve fiber layer, determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in average and for each of the four quadrants.
Measured: 12 months
Rate of Boston keratoprosthesis complications
Rate of Boston keratoprosthesis complications. Complications from the Boston keratoprosthesis include: corneal melt, retroprosthetic membrane formation, retinal detachment, cystic macular edema, extrusion, hypotony, choroidal hemorrhage.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start8 Apr 2020
- Primary completionOct 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Corneal TransplantationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional prospective study on patients receiving a Boston keratoprosthesis type 1, using a retrospective group as the control group.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Harissi-Dagher, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337944
- Sponsor's protocol ID
- CE19.382
- Acronym
- KPro-HP-Endo
- Status last verified
- Jul 2023
- First submitted
- 3 Apr 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szigiato AA, Bostan C, Nayman T, Harissi-Dagher M. Long-term visual outcomes of the Boston type I keratoprosthesis in Canada. Br J Ophthalmol. 2020 Nov;104(11):1601-1607. doi: 10.1136/bjophthalmol-2019-315345. Epub 2020 Feb 17.
PubMed 32066560Wang Q, Harissi-Dagher M. Characteristics and management of patients with Boston type 1 keratoprosthesis explantation--the University of Montreal Hospital Center experience. Am J Ophthalmol. 2014 Dec;158(6):1297-1304.e1. doi: 10.1016/j.ajo.2014.08.037. Epub 2014 Aug 28.
PubMed 25174898Harissi-Dagher M, Durr GM, Biernacki K, Sebag M, Rheaume MA. Pars plana vitrectomy through the Boston Keratoprosthesis type 1. Eye (Lond). 2013 Jun;27(6):767-9. doi: 10.1038/eye.2013.58. Epub 2013 Apr 12.
PubMed 23579405Robert MC, Pomerleau V, Harissi-Dagher M. Complications associated with Boston keratoprosthesis type 1 and glaucoma drainage devices. Br J Ophthalmol. 2013 May;97(5):573-7. doi: 10.1136/bjophthalmol-2012-302770. Epub 2013 Feb 23.
PubMed 23435225Moussally K, Harissi-Dagher M. Long-term complications associated with glaucoma drainage devices and Boston keratoprosthesis. Am J Ophthalmol. 2011 Nov;152(5):883-4; author reply 884-5. doi: 10.1016/j.ajo.2011.07.014. No abstract available.
PubMed 22017851Talajic JC, Agoumi Y, Gagne S, Moussally K, Harissi-Dagher M. Prevalence, progression, and impact of glaucoma on vision after Boston type 1 keratoprosthesis surgery. Am J Ophthalmol. 2012 Feb;153(2):267-274.e1. doi: 10.1016/j.ajo.2011.07.022. Epub 2011 Oct 7.
PubMed 21982110Dohlman CH, Zhou C, Lei F, Cade F, Regatieri CV, Crnej A, Dohlman JG, Shen LQ, Paschalis EI. Glaucoma After Corneal Trauma or Surgery-A Rapid, Inflammatory, IOP-Independent Pathway. Cornea. 2019 Dec;38(12):1589-1594. doi: 10.1097/ICO.0000000000002106.
PubMed 31453878Crnej A, Paschalis EI, Salvador-Culla B, Tauber A, Drnovsek-Olup B, Shen LQ, Dohlman CH. Glaucoma progression and role of glaucoma surgery in patients with Boston keratoprosthesis. Cornea. 2014 Apr;33(4):349-54. doi: 10.1097/ICO.0000000000000067.
PubMed 24531120Khan BF, Harissi-Dagher M, Khan DM, Dohlman CH. Advances in Boston keratoprosthesis: enhancing retention and prevention of infection and inflammation. Int Ophthalmol Clin. 2007 Spring;47(2):61-71. doi: 10.1097/IIO.0b013e318036bd8b. No abstract available.
PubMed 17450007Boscher C, Kuhn F. Endoscopic evaluation and dissection of the anterior vitreous base. Ophthalmic Res. 2015;53(2):90-9. doi: 10.1159/000370032. Epub 2015 Jan 27.
PubMed 25633467Modjtahedi BS, Eliott D. Vitreoretinal complications of the Boston Keratoprosthesis. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):338-48. doi: 10.3109/08820538.2014.959204.
PubMed 25325859Yu YZ, Zou YP, Zou XL. Endoscopy-assisted vitrectomy in the anterior vitreous. Int J Ophthalmol. 2018 Mar 18;11(3):506-511. doi: 10.18240/ijo.2018.03.23. eCollection 2018.
PubMed 29600187