Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes
1 other identifier
observational
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedNovember 27, 2023
November 1, 2023
5.3 years
August 26, 2019
November 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Endothelial cell loss
Change in endothelial cell count from baseline compared to 24 months post-operatively.
Pre-operative (baseline) and 24 weeks post-operatively.
Secondary Outcomes (1)
Corrected distance visual acuity (CDVA)
Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.
Other Outcomes (1)
Secondary adverse events (SAE's)
Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.
Study Arms (2)
Intraocular lens implantation: AC IOL
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
Intraocular lens implantation: SF IOL
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
Interventions
Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.
Eligibility Criteria
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.
You may qualify if:
- 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).
- Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator).
- Decision makers able to provide informed consent.
You may not qualify if:
- Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline.
- Patients unable to attend follow-up visits.
- Patients who have had a corneal transplant prior to secondary IOL implantation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5, Canada
Related Publications (6)
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.
PMID: 25448990BACKGROUNDKrysik 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.
PMID: 30298105BACKGROUNDKwong 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.
PMID: 17070590BACKGROUNDNegretti 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.
PMID: 29219957BACKGROUNDYamane 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.
PMID: 28457613BACKGROUNDBrunin 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.
PMID: 28410720BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Kertes, MD
Sunnybrook Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ophthalmologist - Retina Specialist
Study Record Dates
First Submitted
August 26, 2019
First Posted
August 28, 2019
Study Start
September 1, 2019
Primary Completion
December 30, 2024
Study Completion
January 30, 2025
Last Updated
November 27, 2023
Record last verified: 2023-11