Clinical Outcomes of an New EDOF IOL (Isopure®)
Study Details
Study Description
Brief Summary
Single-center, retrospective, open-label observational study aiming to evaluate visual outcomes and patient satisfaction after bilateral implantation of Isopure® EDOF-IOL with a mono-minovision target.
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Detailed Description
This single-center retrospective study investigates visual outcomes and patient satisfaction in subjects bilaterally implanted with Enhanced-Depth of Focus (EDOF) Isopure® IOL during routine bilateral cataract surgery.
The study is carried out in an ophthalmic clinic in Switzerland. In this study, routine surgical techniques and postoperative follow-up will be applied as for all other (non-study) cataract patients in the clinic. Therefore, all study patients will be operated in immediate consecutive bilateral mode (routine in clinic). Patients participating in this study will be recruited and enrolled postoperatively. They undergo routine postoperative follow-up examinations, and data are collected at the third scheduled examination (4 to 6 weeks after surgery) and at a telephone call 4 to 6 months after surgery.
Isopure 1.2.3 is a CE certified intraocular lens readily available on the market in Switzerland.
The primary outcome consists in demonstrating a preserved distance visual acuity while improving binocular spectacle-free intermediate vision and, to a lesser extent, near vision. Binocular defocus curves are measured for each participant to simulate visual acuity at different distances. Patient satisfaction with treatment and subjective ratings of visual phenomena will be assessed using a modified PRISQ questionnaire and a modified NEI quality of vision questionnaire (RQL-42) at the third postoperative visit and three months after surgery.
At Vista Alpina Eye Clinic, mini-monovision is routinely used to further improve binocular intermediate and near vision while preserving the quality of distance vision in patients implanted bilaterally with EDOF Isopure® IOLs. Analysis of the retrospective data should help support this surgical strategy.
Patients with astigmatism up to 1.5 D benefit intraoperatively from Opposite Clear Corneal Incisions (OCCI) to reduce astigmatism. Analysis of our retrospective data will allow comparison of their visual performance with that of patients without astigmatism who did not require an additional OCCI procedure.
Study Design
Outcome Measures
Primary Outcome Measures
- UDVA(m) [4-6 weeks postoperatively]
Monocular Uncorrected Distance Visual Acuity
- CDVA(m) [4-6 weeks postoperatively]
Monocular Corrected Distance Visual Acuity
- UDVA(b) [4-6 weeks postoperatively]
Binocular Uncorrected Distance Visual Acuity
- UIVA [4-6 weeks postoperatively]
Binocular Uncorrected Intermediate Visual Acuity (80 cm)
- UNVA [4-6 weeks postoperatively]
Binocular Uncorrected Near Visual Acuity (40 cm)
- Defocus curve [4-6 weeks postoperatively]
Binocular distance-corrected defocus curve analysis simulating visual acuities at different distances.
Secondary Outcome Measures
- Patient satisfaction with the visual outcome [4-6 weeks postoperatively and 4-6 months postoperatively]
(modified) PRISQ questionnaire
- Subjective rating of visual phenomena [4-6 weeks postoperatively and 4-6 months postoperatively]
(modified) NEI quality of vision questionnaire (RQL-42, questions 17 and 38)
Other Outcome Measures
- Impact of OCCI on residual refractive cylinder [4-6 weeks postoperatively]
Residual refractive cylinder in eyes undergoing OCCI (eyes with preoperative topographic total corneal astigmatism 0.6 - 1.5 diopters), compared to eyes not having undergone OCCI (preoperative topographic cylinder 0 - 0.5 diopters).
- Impact of OCCI on uncorrected binocular visual acuity [4-6 weeks postoperatively]
Comparison of binocular UDVA between three subgroups. Subgroup 1: both eyes having undergone OCCI. Subgroup 2: one eyes having undergone OCCI. Subgroup 3: none of the eyes having undergone OCCI.
- Impact of OCCI on uncorrected monocular visual acuity [4-6 weeks postoperatively]
Comparison of monocular UDVA between eyes having undergone OCCI and eyes not having undergone OCCI (eyes with emmetropic objective only)
- Accuracy of different IOL-formulas [4-6 weeks postoperatively]
Comparing various IOL-formulas used to calculate the appropriate IOL power during preoperative assessment. The objective is to determine which IOL formulas are most accurate, overall, and (subgroups) in function of the anatomy of the eye (short vs long eyes, shallow versus deep anterior chamber)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients aged 50 years or older undergoing a routine cataract surgery and benefiting from bilateral IOL implantation with Isopure 1.2.3 IOL;
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Patient's willingness to participate in the study;
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Capacity to understand and sign an informed consent form and comply with examination procedures;
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Cataractous eyes with no vision-impacting comorbidity (estimated visual potential post-surgery 0.2 logMAR or better);
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Regular total corneal astigmatism ≤1.5 D (measured by topography method)
Exclusion Criteria:
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Cooperation difficulties (distance from home, general health conditions, cognitive impairment);
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Subjects with diagnosed extra- or intraocular vision-affecting comorbidities (macular degeneration, glaucoma or other retinal or optic nerve disorders, previous ocular surgeries, amblyopia);
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Patients who previously benefitted from refractive surgery (PRK/LASIK) were included if no refractive surgery-related complications were noted (i.e: ectasia, corneal haze, dry eye);
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History or presence of macular edema;
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Perioperative complications;
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Congenital, uveitic, traumatic or surgically-complicated cataract
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Regular total corneal astigmatism >1.5 dioptres (measured by topography method)
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Irregular cornea, including keratotomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vista Alpina Eye Clinic | Visp | Switzerland | 3930 |
Sponsors and Collaborators
- Kristof Vandekerckhove, MD, MBA
Investigators
- Principal Investigator: Kristof Vandekerckhove, MD, Vista Alpina Eye Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Iso123