Grantham Hospital
Hong Kong
NCT Number: NCT06383754
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.
Looking for future studies?
Notify Me50 year–80 year
All sexes
Interventional
Not applicable
Hong Kong
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Monofocal intraocular lens
Monofocal 1 Piece intraocular lens
Time frame: 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.
Time frame: 1 week, 1 month and 6 months
Visual acuity will be measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Time frame: 1 week, 1 month and 6 months
Refraction will be measured by an autorefractor, and the unit of measurement is Diopter.
Time frame: 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.
Time frame: 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.
Time frame: 1 week, 1 month and 6 months
Any surgical complications and post operative complications will be documented.
The University of Hong Kong
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05646004
Senile Cataract
Qionghai, Hainan, China
View Trial DetailsNCT06192901
Senile Cataract
San Salvador, El Salvador
View Trial DetailsNCT05014269
Corneal Diseases, Corneal Opacity
View Trial DetailsNCT04972435
Eye Diseases, Glaucoma
Bangkoknoi, Bangkok, Thailand
View Trial Details