Corneal Endothelial Cell LossNCT04072978
Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes
An observational study of Corneal Endothelial Cell Loss and Secondary Intraocular Lens, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Endothelial Cell Loss, Secondary Intraocular Lens
- What is being tested?
- Intraocular lens implantation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
Cindy Rutz, 416 480 5091, cindy.rutz@sunnybrook.ca
Faryal Maniyali, 416 480 6100 ext. 2870, faryal.maniyali@sunnybrook.ca
About this study
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).
Read the 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.
- Being tested
- Intraocular lens implantation
- Medical subject headings
- Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lens implantationDevice
Also called IOL implantation
Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Intraocular lens implantation | |
| 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 Receives: Device: Intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell loss
Change in endothelial cell count from baseline compared to 24 months post-operatively.
Measured: Pre-operative (baseline) and 24 weeks post-operatively.
Secondary outcomes (1)
Corrected distance visual acuity (CDVA)
CDVA will be measured using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Measured: Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Corneal Endothelial Cell LossStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Kertes, Sunnybrook Health Sciences Centre
- Investigators
- Peter Kertes, MD, Principal investigator, Sunnybrook Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072978
- Sponsor's protocol ID
- 00046460
- Status last verified
- Nov 2023
- First submitted
- 26 Aug 2019
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25448990Krysik 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.
PubMed 30298105Kwong 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.
PubMed 17070590Negretti 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.
PubMed 29219957Yamane 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.
PubMed 28457613Brunin 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.
PubMed 28410720
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes
- ClinicalTrials.gov ID
- NCT04072978
- Acronym / sponsor ID
- 00046460
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraocular lens implantation: AC IOL | – | Device: Intraocular lens implantationPatients 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 | – | Device: Intraocular lens implantationPatients 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 |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular lens implantationAlso: IOL implantationImplantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique. | Device | Intraocular lens implantation: AC IOL, Intraocular lens implantation: SF IOL |
Primary outcome
Endothelial cell loss
Time frame: Pre-operative (baseline) and 24 weeks post-operatively.
Change in endothelial cell count from baseline compared to 24 months post-operatively.
1 secondary outcome
Corrected distance visual acuity (CDVA)
Time frame: Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 25448990Chan 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.
- Background: PubMed 30298105Krysik 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.
- Background: PubMed 17070590Kwong 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.
- Background: PubMed 29219957Negretti 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.
- Background: PubMed 28457613Yamane 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.
- Background: PubMed 28410720Brunin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kertes, MD principal investigator
Sunnybrook Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Endothelial Cell Loss and Secondary Intraocular Lens, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cindy Rutz (416 480 5091, cindy.rutz@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell loss (time frame: Pre-operative (baseline) and 24 weeks post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072978, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.