Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04907318 |
| Other study ID # |
PHY PODT-POD FT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
July 1, 2016 |
Study information
| Verified date |
May 2021 |
| Source |
Beaver-Visitec International, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary objective of the study is to observe the rotational stability of the implant 30
minutes, one day, 6 weeks, 6 months and 12 months after the implant surgery. In addition, the
refraction will be measured as it is directly affected in the event of postoperative
rotation. The correlation between postoperative rotation and the following parameters will be
determined: PEXS, white-to-white, age, axial length, anterior chamber depth. Visual acuities
with and without correction and the best refraction to assess the benefit of the implants
will also be investigated.
Description:
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.
