Condition category
Eye Diseases
Date applied
17/04/2008
Date assigned
25/11/2008
Last edited
25/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stanislawa Gierek-Ciaciura

ORCID ID

Contact details

University Hospital No. 5 of the Medical University of Silesia
Ceglana 35
Katowice
40-952
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To compare the patients visual results after bilateral implantation of ReZoom™ multifocal intraocular lens (IOL) (NXG1, Advanced Medical Optics), AcrySof® ReSTOR® IOL (SA60D3, Alcon Laboratories) and Tecnis® multifocal IOL (ZM900, Advanced Medical Optics).

Ethics approval

Standard procedure of cataract removal with implantation of intraocular lenses being in common usage means that no ethics board approval was required.

Study design

Single-centre, interventional, non-randomised, non-masked study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cataract

Intervention

Phacoemulsification and aspiration of lens mass were carried out with the Infiniti® Vision System (Alcon Laboratories, Inc.) or Sovereign® Compact (Advanced Medical Optics, Inc.) through 2.8 - 3.0 mm in upper temporal quadrant of transparent cornea with no sutures used and consequent artificial lens implantation to native lens capsule with a single-use injector.

The candidates were provided detailed information concerning the structure and action of each tested multifocal implant and they expressed which type of intraocular lens they would like to have implanted. The doctor also tried to assess the best option for each involved individual based on performing job and lifestyle. Definite reply depended on patient. Follow-up was 6 month in all eyes (from 6 to 13 months).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Evaluation of anterior and posterior segments of the eyeball with slit lamp biomicroscope
2. Examination of uncorrected distance visual acuity (UCDVA) and best distance corrected visual acuity (BDCVA) (logarithm of the minimum angle of resolution [LogMAR] and Snellen's chart)
3. Examination of uncorrected near visual acuity (UNVA) and best distance corrected near visual acuity (BDCNA) (Jaeger reading chart)
4. Axial length
5. Intraocular pressure
6. Measurement of corneal endothelial cell density
7. Contrast sensitivity measurement with CSV-1000 test (Vector Vision)
8. Evaluation of pupil size
9. Measurement of eye aberration with aberrometer WASCA (Carl Zeiss, Inc.)

The primary outcomes were measured 1 day, 1 week, 1, 3 and 6 months after surgery.

Secondary outcome measures

1. Spectacle dependency
2. Subjective satisfaction with vision using the 14-item Visual Function (VF-14) survey

The secondary outcomes were measured 3 and 6 months after procedure.

Overall trial start date

05/10/2005

Overall trial end date

29/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 40 - 75 years, either sex
2. Visual acuity equal to or less than 0.7 according to Snellen’s chart
3. Cataract in both eyes classified according to the Lens Opacities Classification System III (LOCS III)
4. Astigmatism less than 1.5 D
5. Mesopic pupil larger than 3.0 mm
6. Lack of other ophthalmological illnesses, such as:
6.1. Post-transplant cornea
6.2. Irregular astigmatism
6.3. Chronic uveoscleritis
6.4. Damage to ciliary/zonular system of lens
6.5. Pseudoexfoliation syndrome
6.6. Glaucoma
6.7. Previous refractive and anti-glaucomatous operations
6.8. Diabetic retinopathy
6.9. Macular degeneration

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Thirty patients

Participant exclusion criteria

1. Age below 45 and more than 75 years
2. Any other diseases besides cataract
3. Unrealistic expectations concerning vision
4. Patients practising professions which required night-time driving

Recruitment start date

05/10/2005

Recruitment end date

29/05/2007

Locations

Countries of recruitment

Poland

Trial participating centre

University Hospital No. 5 of the Medical University of Silesia
Katowice
40-952
Poland

Sponsor information

Organisation

University Hospital No. 5 of the Medical University of Silesia, Katowice (Poland)

Sponsor details

Ul. Ceglana 35
Katowice
40-952
Poland

Sponsor type

Hospital/treatment centre

Website

http://www.kli-okul.katowice.pl

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital No. 5 of the Medical University of Silesia, Katowice (Samodzielny Publicsny Szpital Kliniczny Nr 5 Śląski Uniwersytet Medyczny w Katowicach) (Poland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes