Corneal Endothelial Cell Loss, Secondary Intraocular Lens
Conditions
Brief summary
This is a prospective comparative non-randomized cohort study to understand the long-term vision outcomes, safety, and stability of anterior chamber intraocular lenses (AC IOLs) vs. scleral-fixated intraocular lenses (SF IOLs).
Detailed description
On the pre-operative visit, specular microscopy, biometry, applanation tonometry and ocular coherence tomography (OCT) will be performed. The patient will then undergo treatment as per surgeon's discussion/ decision with the patient for implantation of an AC-IOL or SF-IOL. Participation in the study will not impact the management plan in any way. Specular microscopy will be performed wit the CellChek XL (Konan Medical, Irvine, CA). Biometry will be performed with the IOLMASTER (Carl Ziess Meditec, Jena, Germany), and anterior segment and macular OCT will be performed with the Cirrus-HD OCT (Carl Zeiss Metidec, Jena, Germany). EC count, OCT (macula and anterior segment) and specular microscopy will be performed at baseline, week 1, month 1, month 6, 12 and 24.
Interventions
Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients who are undergoing AC IOL or SF IOL implantation for any reason (including but not limited to aphakia, posterior capsular rupture, primary or secondary lens dislocation/ subluxation or IOL exchange). 2. Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator). 3. Decision makers able to provide informed consent.
Exclusion criteria
1. Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline. 2. Patients unable to attend follow-up visits. 3. Patients who have had a corneal transplant prior to secondary IOL implantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial cell loss | Pre-operative (baseline) and 24 weeks post-operatively. | Change in endothelial cell count from baseline compared to 24 months post-operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corrected distance visual acuity (CDVA) | Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively. | CDVA will be measured using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart |
Other
| Measure | Time frame | Description |
|---|---|---|
| Secondary adverse events (SAE's) | Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively. | Occurrence of cystoid macular edema (CME), retinal detachment, UGH syndrome, vitreous or choroidal hemorrhage, lens subluxation/ dislocation, glaucoma, uveitis, etc. |
Countries
Canada
Contacts
Primary ContactCindy Rutz
Backup ContactFaryal Maniyali
Outcome results
None listed