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

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Secondary Intraocular Lens; Corneal Endothelial Cell Loss

Treatments: Device: Intraocular lens implantation

Study type: Observational

Funder types: Other

Identifiers

NCT04072978

00046460

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Intraocular lens implantation: AC IOL

Description:

Patients who are scheduled to undergo AC IOL (anterior chamber intraocular lens) implantation for any of the following indications: * primary or secondary aphakia * primary or secondary lens subluxation or dislocation

Treatment:

Device: Intraocular lens implantation

Intraocular lens implantation: SF IOL

Description:

Patients who are scheduled to undergo SF IOL (scleral fixated intraocular lens) implantation for any of the following indications: * primary or secondary aphakia * primary or secondary lens subluxation or dislocation

Treatment:

Device: Intraocular lens implantation