Clinical trial NCT04072978: Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes
Official title: Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corneal Endothelial Cell Loss
Secondary Intraocular Lens
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are planned to undergo surgical implantation of an anterior chamber intraocular lens or a scleral-fixated IOL who present to the study investigators as part of the vitreoretinal surgery team at Sunnybrook Hospital or the Toronto Western Hospital.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Endothelial cell loss
timeFrame: Pre-operative (baseline) and 24 weeks post-operatively.
Secondary outcomes:
measure: Corrected distance visual acuity (CDVA)
timeFrame: Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.
Other outcomes:
measure: Secondary adverse events (SAE's)
timeFrame: Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Hospital
name: Peter Kertes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan TC, Lam JK, Jhanji V, Li EY. Comparison of outcomes of primary anterior chamber versus secondary scleral-fixated intraocular lens implantation in complicated cataract surgeries. Am J Ophthalmol. 2015 Feb;159(2):221-6.e2. doi: 10.1016/j.ajo.2014.10.016. Epub 2014 Oct 22.
citation: Krysik K, Dobrowolski D, Wroblewska-Czajka E, Lyssek-Boron A, Wylegala E. Comparison of the Techniques of Secondary Intraocular Lens Implantation after Penetrating Keratoplasty. J Ophthalmol. 2018 Sep 12;2018:3271017. doi: 10.1155/2018/3271017. eCollection 2018.
citation: Kwong YY, Yuen HK, Lam RF, Lee VY, Rao SK, Lam DS. Comparison of outcomes of primary scleral-fixated versus primary anterior chamber intraocular lens implantation in complicated cataract surgeries. Ophthalmology. 2007 Jan;114(1):80-5. doi: 10.1016/j.ophtha.2005.11.024. Epub 2006 Oct 27.
citation: Negretti GS, Lai M, Petrou P, Walker R, Charteris D. Anterior chamber lens implantation in vitrectomised eyes. Eye (Lond). 2018 Mar;32(3):597-601. doi: 10.1038/eye.2017.261. Epub 2017 Dec 8.
citation: Yamane S, Sato S, Maruyama-Inoue M, Kadonosono K. Flanged Intrascleral Intraocular Lens Fixation with Double-Needle Technique. Ophthalmology. 2017 Aug;124(8):1136-1142. doi: 10.1016/j.ophtha.2017.03.036. Epub 2017 Apr 27.
citation: Brunin G, Sajjad A, Kim EJ, Montes de Oca I, Weikert MP, Wang L, Koch DD, Al-Mohtaseb Z. Secondary intraocular lens implantation: Complication rates, visual acuity, and refractive outcomes. J Cataract Refract Surg. 2017 Mar;43(3):369-376. doi: 10.1016/j.jcrs.2016.12.024.