Glaucoma Clinical Trial
— GDD-KProOfficial title:
Timing of Glaucoma Drainage Device Implantation With Boston Keratoprosthesis Surgery
Boston keratoprosthesis (KPro) is a piece of specialized plastic that replace sick cornea (transparent structure at the front of the eye) in patients who have failed or those who are expected to have poor results with traditional corneal transplantation. While the Kpro can offer dramatic improvement in vision, it is also associated with several complications. Glaucoma (optic nerve damage due to high pressure inside the eye) is one of the most common complications after KPro surgery and can potentially cause irreversible vision loss. The implantation of a glaucoma drainage device (GDD), a tiny tube that drains the liquid inside the eye by bypassing the natural drainage system, is an effective option to lower the eye pressure in patients with KPro. Given the frequency and potentially devastating effects of glaucoma among KPro patients, some surgeons recommend to put in a GDD as a preventative measure. However, there is no consensus on when is the best timing to perform such surgery in relation to the Boston Kpro surgery. Hypothesis: For patients undergoing the Boston KPro surgery, implanting a GDD simultaneously, at the time of surgery, is more efficacious than at 6 months later, in the prevention of the progression of glaucoma and in maintaining better visual functions. Methods: The investigators aim to recruit 40 patients over 4 years. Recruited patients will be randomly assigned to 2 groups: 1) simultaneous GDD implantation at the Boston KPro surgery, and 2) GDD implantation 6 months after the Boston KPro surgery. Once recruited, patients will be followed before the KPro surgery, postoperative day 1, week 1, month 1, 3, 6 and 12. Standard ophthalmological exam will be performed at each visit. Additional non-invasive glaucoma tests and evaluation (visual fields and optic nerve photo) will be performed on day 1, month 1, 3, 6 and 12. For patients assigned to group 2, a GDD will be implanted 6 months after the KPro surgery. They will have additional follow-ups on post-GDD surgery day 1, week 1 and month 1. Results of visual acuity, visual fields, optic nerve evaluation and complications will be compared between the two groups to determine the better timing of GDD implantation.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Candidate for corneal transplantation due to loss of corneal clarity - Verifiable history of one or more previous full thickness donor corneal transplantation failure - Pre-operative visual acuity of =20/80 or worse in the surgical eye - Age =18 years - Physical condition suitable for undergoing surgery Exclusion Criteria: - Terminal glaucoma - Terminal retinal diseases |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Aldave AJ, Kamal KM, Vo RC, Yu F. The Boston type I keratoprosthesis: improving outcomes and expanding indications. Ophthalmology. 2009 Apr;116(4):640-51. doi: 10.1016/j.ophtha.2008.12.058. Epub 2009 Feb 25. — View Citation
Banitt M. Evaluation and management of glaucoma after keratoprosthesis. Curr Opin Ophthalmol. 2011 Mar;22(2):133-6. doi: 10.1097/ICU.0b013e328343723d. — View Citation
Chew HF, Ayres BD, Hammersmith KM, Rapuano CJ, Laibson PR, Myers JS, Jin YP, Cohen EJ. Boston keratoprosthesis outcomes and complications. Cornea. 2009 Oct;28(9):989-96. doi: 10.1097/ICO.0b013e3181a186dc. — View Citation
Talajic 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual field mean deviation | Humphrey Visual Field 24-2 (SITA-Fast) (or Goldmann if poor vision/reliability) | Change from baseline visual field mean deviation at 12 months | |
Secondary | Disc Damage Likelihood Scale (DDLS) on clinical examination | Evaluation by a glaucoma specialist using the slit-lamp apparatus. | Change from baseline DDLS on clinical examination at 12 months | |
Secondary | Disc Damage Likelihood Scale (DDLS) on stereoscopic photographs of the optic nerve | Outcome assessed by a glaucoma specialist blinded to previous DDLS score | Change from baseline DDLS on optic nerve photographs at 12 months | |
Secondary | Incidence of ocular complications | All ocular complications reported by post-KPro 12 months | 12 months after KPro | |
Secondary | Change of visual acuity | Change of visual acuity compared between before and after surgery. The visual acuity is measured using the Snellen chart and expressed in logMAR. | 12 months after KPro |
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