Epiretinal Membrane, Senile Cataract, Vitreous Hemorrhage
Conditions
Brief summary
This prospective randomized controlled trial will be conducted to investigate Clareon intraocular lens (IOL) stability in vitrectomy patients. The investigator plans to target the patients undergoing cataract surgery. A randomized study will be conducted with 2 arms, one with Clareon IOL versus a second arm using the Tecnis 1 In this non-inferiority study, the investigator will compare Clareon IOL from Alcon with the existing Tecnis 1 IOL from Precision Lens which is the commonly used intraocular lens in combined vitrectomy cases in Hong Kong.
Detailed description
All patients will undergo standard phacoemulsification cataract extraction with Clareon IOL or Tecnis 1 IOL by an experienced cataract surgeon. Followed by vitrectomy to treat either, epiretinal membrane or vitreous hemorrhage. All patients returned for follow-up visits at 1 week, 1 month, and 6 months after surgery for ophthalmic assessments including: * Visual acuity measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart * Refraction * Axial movement and tilt measured by Pentacam (OCULUS Optikgeräte GmbH, Germany) using the Sasaki method. The Scheimpflug image of the horizontal cross-section and the vertical cross-section of the IOL will be selected for measurement. Central ACD will be measured as the distance between the central corneal posterior endothelium to the anterior surface of IOL. The subtraction in ACD between two visits indicated forward or backward axial movement of the IOL. * Decentration will be measured from the center of the IOL anterior surface to the pupillary axis, which will be perpendicular to the line between the two anterior chamber angles and through the midpoint of the line. * Tilt will be measured as the angle between the IOL axis and the perpendicular visual axis. * Any surgical complications and post-op complications will be documented.
Interventions
DEVICEClareon
Monofocal intraocular lens
DEVICETecnis 1
Monofocal 1 Piece intraocular lens
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients are randomised and masked from the treatment
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of senile cataracts and epiretinal membranes or vitreous hemorrhage * Age between 50 and 80 years.
Exclusion criteria
* Diagnosis of vision-impairing diseases including uveitis, glaucoma and corneal pathologies resulting in high astigmatism, severe refractive error (preoperative spherical equivalent of either eye \>-6.00D or +5.00D); * Diagnosis of possible lenses instability including History of ocular trauma, Pseudoexfoliation syndrome; past refractive surgery or other ophthalmic surgery; * Known Capsular or zonular disorders that might affect the post-operative centration of IOLs, e.g., pseudo-exfoliation syndrome or Marfan syndrome; * Surgical complications including severe hyphema, iris injury, repeated IOL implantation during surgery, failure to achieve in-the-bag IOL implantation, posterior capsular rupture, usage of tamponade (gas or oil) and corneal sutures. * Difficulty in obtaining IOL measurements (eg. Small pupil, corneal opacities, patient cooperation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Position stability of Clareon and Tecnis 1 IOL | 1 week, 1 month and 6 months | Two arms will compare Intraocular lens stability, which will be measured by it's tilt, measures in degrees from iris plane (0, deg). Tilt will be measured using Pentacam by Sasaki method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 1 week, 1 month and 6 months | Visual acuity will be measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart |
| Refraction | 1 week, 1 month and 6 months | Refraction will be measured by an autorefractor, and the unit of measurement is Diopter. |
| Axial movement | 1 week, 1 month and 6 months | Axial movement will be measured by Pentacam (OCULUS Optikgeräte GmbH, Germany) using the Sasaki method. For axial movement unit of measurement is millimeter. |
| Decentration | 1 week, 1 month and 6 months | Decentration will be measured from the center of the IOL anterior surface to the pupillary axis, which will be perpendicular to the line between the two anterior chamber angles and through the midpoint of the line. The unit of measurement for decentration is millimeter. |
| Compare intra operative and post operative complication | 1 week, 1 month and 6 months | Any surgical complications and post operative complications will be documented. |
Countries
Hong Kong
Outcome results
None listed