Evaluating a new intraocular lens for cataract surgery
Evaluation of the Long-term Efficacy and Safety of Monofocal Plate Haptic Intraocular Lens to be Implanted Into the Eye in Patients Undergoing Cataract Surgery
NA · Yuzuncu Yıl University · NCT06238271
This study is testing a new type of lens for cataract surgery to see if it helps people see better and is safe over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yuzuncu Yıl University (other) |
| Locations | 1 site (Van) |
| Trial ID | NCT06238271 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the long-term efficacy and safety of the monofocal plate haptic intraocular lens in patients undergoing cataract surgery. A total of 300 eyes will be evaluated at Van Yüzüncü Yıl University, with pre-and postoperative assessments including visual acuity, subjective refraction, and various ocular examinations. The study will monitor for complications associated with the lens implantation over a 12-month period. Data will be analyzed to determine the effectiveness and reliability of the lens in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for cataract surgery who can provide informed consent and meet specific biometry criteria.
Not a fit: Patients with preoperative visual acuity better than 0.3 logMAR or those likely to be non-compliant with the study protocol may not benefit.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective option for patients undergoing cataract surgery.
How similar studies have performed: Other studies have shown promising results with similar intraocular lens approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent; * Patients of any gender * Assured follow-up examinations * Biometry measurement preferably compatible with the Lenstar evaluation; * IOL implanted into the capsular bag with IOL model Acriva BB UDM 611 (UVE material) in one or both eyes Exclusion Criteria: * BCVA not available preoperatively or better than 0.3 logMAR pre-op * Patients unable to meet the limitations of the protocol or likely to non-cooperation during the trial * Patients with peroperative complications (Such as capsulorhexis problems that affect centralization, failure of the IOL implanting into the bag, posterior capsular rupture, iris damage, vitreous loss, IOL damage, etc.)
Where this trial is running
Van
- Van Yuzuncu Yil University — Van, Turkey (RECRUITING)
Study contacts
- Study coordinator: Erbil Seven, MD, Associate Professor
- Email: erbilseven@gmail.com
- Phone: +90 (432) 2150474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lens Implantation, Intraocular, Cataract, Intraocular lens implantation, Phacoemulsification