An observational study in Lens Opacities, Cataract and Pseudophakia, sponsored by Kristof Vandekerckhove, MD, MBA. Completed at 1 site in Switzerland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Kristof Vandekerckhove, MD, MBA · Observational
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.
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.
Consecutive patients undergoing routine cataract surgery and having opted for the implantation of an EDOF intraocular lens, in a primary ophthalmic clinic in Switzerland.
Exclusion Criteria:
Bilateral Isopure 1.2.3 intraocular EDOF IOL implantation during a routine cataract surgery.
UDVA(m)
Monocular Uncorrected Distance Visual Acuity
Time frame: 4-6 weeks postoperatively
CDVA(m)
Monocular Corrected Distance Visual Acuity
Time frame: 4-6 weeks postoperatively
UDVA(b)
Binocular Uncorrected Distance Visual Acuity
Time frame: 4-6 weeks postoperatively
UIVA
Binocular Uncorrected Intermediate Visual Acuity (80 cm)
Time frame: 4-6 weeks postoperatively
UNVA
Binocular Uncorrected Near Visual Acuity (40 cm)
Time frame: 4-6 weeks postoperatively
Defocus curve
Binocular distance-corrected defocus curve analysis simulating visual acuities at different distances.
Time frame: 4-6 weeks postoperatively
Patient satisfaction with the visual outcome
(modified) PRISQ questionnaire
Time frame: 4-6 weeks postoperatively and 4-6 months postoperatively
Subjective rating of visual phenomena
(modified) NEI quality of vision questionnaire (RQL-42, questions 17 and 38)
Time frame: 4-6 weeks postoperatively and 4-6 months postoperatively
Impact of OCCI on residual refractive cylinder
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).
Time frame: 4-6 weeks postoperatively
Impact of OCCI on uncorrected binocular visual acuity
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.
Time frame: 4-6 weeks postoperatively
Impact of OCCI on uncorrected monocular visual acuity
Comparison of monocular UDVA between eyes having undergone OCCI and eyes not having undergone OCCI (eyes with emmetropic objective only)
Time frame: 4-6 weeks postoperatively
Accuracy of different IOL-formulas
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)
Time frame: 4-6 weeks postoperatively
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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