Visual Performance With a Hydrophobic Aspheric Monofocal IOL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03819582|
Recruitment Status : Unknown
Verified January 2019 by Dr Phillip J Buckhurst, University of Plymouth.
Recruitment status was: Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: EyeCee One intraocular lens||Phase 4|
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. There are many different designs of monofocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. This research project allows us to assess the visual outcomes of a specific monofocal IOL. It also allows us to assess the ease of use of the lens to the surgeon.
Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month post implantation), Visit 2 (3 months post implantation).
At both post-operative visits the patient will undergo:
Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications
At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens insertion time and ease of use.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: Intraocular lens
Subjects implanted with the EyeCee One Intraocular lens
Device: EyeCee One intraocular lens
Hydrophobic aspheric monofocal intraocular lens
- Visual acuity early post operative [ Time Frame: 1 month post operatively ]Visual acuity measured in LogMAR early post operatively
- Visual acuity after 3 months post operatively [ Time Frame: 3 months post operatively ]Visual acuity measured in LogMAR measured 3 months post operatively
- Ease of use to surgeons [ Time Frame: During surgery ]Questionnaire completed by the surgeon to determine the usability of the intraocular lens
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819582
|Contact: Phillip Buckhurstemail@example.com|
|BMI Southend Hospital||Recruiting|
|Westcliff-on-Sea, Essex, United Kingdom, SS0 9AG|
|Contact: Elizabeth Law firstname.lastname@example.org|