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Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes

Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes

Recruiting
16-99 years
All
Phase N/A

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Overview

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).

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.

Eligibility

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.

Study details
    Corneal Endothelial Cell Loss
    Secondary Intraocular Lens

NCT04072978

Sunnybrook Health Sciences Centre

26 January 2024

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