Skip to content

A Randomised, Single Centre Study of the Equivalence of Two Intraocular Lenses Used in Cataract Surgery

A Randomised, Single Centre Study of the Equivalence in Safety and Efficacy of Two Intraocular Lenses Used in Cataract Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000601437
Enrollment
308
Registered
2007-11-21
Start date
2007-06-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Prospective randomised study is to assess the safety and efficacy of the two intraocular lens (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The assessment of the IOL results will be based on a comparison to the patient’s preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visual and refractive outcomes, as well as an analysis of reported complications.

Interventions

The main objective of this prospective randomised study is to assess the safety and efficacy of the two Intraocular Lenses (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The Tecsoft IOL will be the intervention IOL and the comparator will be the Alcon IOL. The assessment of the IOL results will be based on a comparison to the patient’s preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visu

The main objective of this prospective randomised study is to assess the safety and efficacy of the two Intraocular Lenses (IOL) (Alcon IOL and Tecsoft IOL) in human eyes for the treatment of cataracts. The Tecsoft IOL will be the intervention IOL and the comparator will be the Alcon IOL. The assessment of the IOL results will be based on a comparison to the patient’s preoperative condition (i.e. best spectacle corrected visual acuity and uncorrected vision) and the achieved versus expected visual and refractive outcomes, as well as an analysis of reported complications. The patients will be followed for a one year period at intervals of 0-2 months before surgery, day of surgery (day 0), 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative. The benefit from the two IOL’s studied being equivalent is that the very significantly cheaper Tecsoft IOL could confidently be used in cataract surgery with IOL implantation saving the Australian community millions of health dollars that could more usefully be directed to fund other new and cost effective medical technology.

Sponsors

Centre for Eye Research Australia
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
40 Years to -2147483648 No limit
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria: (i) Uncomplicated age-related cataract (ii) Males and females of at least 40 years of age. (iii) Must understand and provide written informed consent. (iv) Willing and able to return for scheduled postoperative follow-up examinations.

Exclusion criteria

Exclusion criteria: (i) History of/or clinical signs of anterior uveitis in either eye. (ii) Diabetic retinopathy in either eye. (iii) Glaucoma in either eye. (iv) Pseudoexfoliation. (v) Amblyopia in either eye. (vi) Blind in the fellow eye. (vii) Central Corneal Opacity/Fuch’s Dystrophy. (viii) Serious (i.e. life threatening) non-ophthalmic disease which may preclude study completion. (ix) Unwilling or unable to provide written informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026