- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04907318
Comparison Between a Toric Monofocal and Multifocal Intraocular Lens
Retrospective Study Analysing the Results of Toric and Toric Multifocal Intraocular Lens Implantation During Cataract Surgery.
Studieoversikt
Detaljert beskrivelse
This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher. They had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.
Inclusion criteria for research participants.
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included. Exclusion criteria for research participants. To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
3 - Adopted observation or investigation method This study involves the collection of data in patient records that fall within the normal framework of cataract surgery.
The demographic and clinical data collected will be the yeat of birth and patient's gender, including ocular or general comorbidities (such as diabetes or rheumatoid illnesses) justifying the visual acuity performance.
The preoperative data collected will be: visual acuity, intraocular pressure, cell density of the corneal endothelium, axial length and corneal power in both axes (data required to routinely calculate the power of the implant and entered into the record to understand any postoperative refractive errors).
The intraoperative data will be the power of the implant and any complications, if applicable.
The postoperative data will be data collected during the standard postoperative follow-up performed at 30 minutes, 1 day, one week, 6 weeks, 6 months and 1 year, with patient questioning, slit lamp observation with implant position, measuring intraocular pressure, determining the best refraction and measuring visual acuity with and without correction (near, far and intermediate vision).
4 - Origin and nature of collected personal data Reason for using this data Observations will be obtained by the doctor from patient records. Clinical data will be used to link potential poor postoperative visual acuity and a comorbidity.
Refractive data will help determine the implant stability in the eye in terms of its depth, i.e. in the sagittal plane, and its rotational stability, i.e. coronal plane stability.
Changes will determine its stability in the coronal plane around the visual axis.
The intraocular pressure analysis and slit lamp examination will help determine the eye inflammatory status before and after surgery.
The record of postoperative keratometry values will help determine whether the error or a refractive change caused by the corneal instability or by the change in the implant position.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Visp, Sveits, 3930
- Vista Alpina Eye Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included.
Exclusion Criteria:
To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
- Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
ANKORIS
Cataract surgery performed with POD26PAYT
|
|
FINEVISION TORIC
Cataract surgery performed with POD26PAYFT
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To observe the rotational stability of the implant
Tidsramme: 6 Months
|
Observation of rotational stability of the implant
|
6 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Visual Acuity
Tidsramme: 6 Months
|
To assess the visual acuities with and without correction and the best refraction to assess the benefit of the implants
|
6 Months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Kristof Vandekerckhove, MD, Vista Alpina Eye Cente, Visp, Switzerland, 3930
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PHY PODT-POD FT
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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