Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation
Primary Purpose
Aphakia, Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Doubled sutured SFIOL
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia
Eligibility Criteria
Inclusion Criteria:
- Adult patients with phacodonesis, lens subluxation, insufficient capsular or zonular support, or surgical aphakia without adequate ciliary sulcus who are listed for scleral fixation intraocular lens implantation.
Exclusion Criteria:
- Patients with previous corneal transplantation surgery or undergoing concomitant corneal transplantation at the time of scleral fixation intraocular lens implantation.
- Patients undergoing concomitant vitreoretinal surgery at the time of intraocular lens implantation.
- Monocular patients, or patients whose fellow eye had vision of equal or less than 20/200.
- Patients who could not comprehend the risks and benefits of the surgery and/or the research study, including mentally incapacitated persons.
- Patients with pre-existing macular pathologies including macular oedema, haemorrhage, degeneration or scar.
- Patients with pre-existing iris abnormalities including aniridia, corectopia, extensive anterior synechiae formation resulting in inability to measure the IOL tilting postoperatively.
- Patients with significantly reduced corneal endothelial cell density (of < 1000 cells/mm2) preoperatively which may necessitate a corneal transplantation.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
The intervention arm will undergo the modified sutured SFIOL technique with double Prolene sutures instead of a single Prolene suture
Outcomes
Primary Outcome Measures
Proportion of eyes with intraoperative, early (within 1 week) and late (at 12 months) postoperative complications following this modified technique of intraocular lens fixation.
Complication Rate
Secondary Outcome Measures
Unaided and corrected visual acuities
Visual acuities
Intraocular lens tilting
Anterior segment optical coherence tomography
endothelial cell status
specular microscopy
Full Information
NCT ID
NCT04516889
First Posted
August 14, 2020
Last Updated
August 14, 2020
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04516889
Brief Title
Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation
Official Title
Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cataract is the leading cause of blindness globally and cataract surgery with the implantation of intraocular lens (IOL) is the most commonly performed operation worldwide. After removal of the cataract, an IOL is usually implanted within the capsular bag. However, endocapsular implantation of IOL is not always feasible due to inadequate zonular or capsular support, intraoperative posterior capsule rupture, or in primary intracapsular cataract extraction. Predisposing factors including prior ocular trauma, intravitreal injection or intraocular surgery, co-existing ocular comorbidities like chronic uveitis, pseudoexfoliation syndrome, may increase the risk of failure of in-the-bag implantation.
In such situation, the surgeons may consider implanting the IOL in the anterior chamber, ciliary sulcus, or using fixation techniques. In Asian eyes, the anterior chambers are often shallow and placement in anterior chamber may accelerate corneal endothelial cell loss leading to corneal decompensation, or worsen pre-existing glaucoma. Placement in the ciliary sulcus depends on the amount and integrity of the capsular remnant, and inadequate support may result in dislocation of the IOL. In recent years, newer forms of scleral fixation of IOL using glue or glue-less approach, although these procedure appeared to be simpler, the long-term stability of these IOL have not been evaluated against conventional approach with suture fixation. The main limitations of suture fixation technique are related to the sutures either intraoperatively (e.g. entanglement, failure to rotate and bury the suture knot) or postoperatively (breakage, dissolution of suture with time), and the learning curve required for surgeons in training.
Our study aims to study the efficacy and safety of a modified technique of scleral fixation of an intraocular lens in the posterior chamber.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention arm will undergo the modified sutured SFIOL technique with double Prolene sutures instead of a single Prolene suture
Intervention Type
Procedure
Intervention Name(s)
Doubled sutured SFIOL
Intervention Description
Recruited subjects would undergo implantation of SFIOL with the modified technique under either local or general anesthesia. The surgeon would mark the sclerotomies as per routine sutured SFIOL at 2mm behind the nasal and temporal limbus, followed by passage of 2 pairs of prolene sutures. The intraocular lens with islets would be implanted into the posterior chamber and sutured to the sclera as per single suture SFIOL.
Primary Outcome Measure Information:
Title
Proportion of eyes with intraoperative, early (within 1 week) and late (at 12 months) postoperative complications following this modified technique of intraocular lens fixation.
Description
Complication Rate
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Unaided and corrected visual acuities
Description
Visual acuities
Time Frame
up to 12 months
Title
Intraocular lens tilting
Description
Anterior segment optical coherence tomography
Time Frame
up to 12 months
Title
endothelial cell status
Description
specular microscopy
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with phacodonesis, lens subluxation, insufficient capsular or zonular support, or surgical aphakia without adequate ciliary sulcus who are listed for scleral fixation intraocular lens implantation.
Exclusion Criteria:
Patients with previous corneal transplantation surgery or undergoing concomitant corneal transplantation at the time of scleral fixation intraocular lens implantation.
Patients undergoing concomitant vitreoretinal surgery at the time of intraocular lens implantation.
Monocular patients, or patients whose fellow eye had vision of equal or less than 20/200.
Patients who could not comprehend the risks and benefits of the surgery and/or the research study, including mentally incapacitated persons.
Patients with pre-existing macular pathologies including macular oedema, haemorrhage, degeneration or scar.
Patients with pre-existing iris abnormalities including aniridia, corectopia, extensive anterior synechiae formation resulting in inability to measure the IOL tilting postoperatively.
Patients with significantly reduced corneal endothelial cell density (of < 1000 cells/mm2) preoperatively which may necessitate a corneal transplantation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Wai Kam
Phone
+852 3505 2879
Email
dr.kwa.kam@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jackey Tse
Phone
+852 3505 2879
Email
jackey@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvin L Young
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation
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