Intraocular Lens Power Calculation Using Pre- and Intra-operative Measurements

NCT02513134 | Completed

• 1 other identifier: OC3
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Recently a prototype of a combination of an anterior segment OCT (VISANTE; Carl Zeiss Meditec AG) and an operating microscope (OPMI 200; Carl Zeiss Meditec AG) was introduced that allows measurements of the crystalline lens as well as the lens capsule itself after removing the crystalline lens of cataract patients intra-operatively. This device uses OCT technology to create high resolution B-scans (=images) of the anterior segment of the eye. The OCT was shown to be highly reproducible for ACD measurements pre-operatively 12 and small changes of the IOL/crystalline lens can be detected 13. In a previous study (EK-10-125-0710) that was recently published in the journal "Investigative Ophthalmology \& Visual Science" it was shown that intra-operative measurements of the anterior lens capsule improve the refractive outcome theoretically.14 However, in this previous study conventional eye models were used for IOL power calculation and only the intra-operative measurement replaced pre-operative ACD measurements. Aim of this study is to observe, whether the postoperative refractive outcome could be improved theoretically by using both pre- and intra-operative measurements for retrospective IOL power calculation with new eye models.

Conditions

Cataract

Keywords

IOL power calculations; Intraoperative; OCT; Refractive outcome; Biometry

Outcome Measures

Primary Outcomes (1)

• spherical equivalent in diopters between groups

  8 weeks postoperatively

Secondary Outcomes (3)

• Anterior chamber depth changes in mm between intra-operative OCT measurements and 1h post-operative ACD measurements

  1 hour postoperatively

• Influence of the lens thickness on IOL power calculation

  8 weeks postoperatively

• Influence of post-operative tilt in degrees and decentration in mm on IOL power calculation

  8 weeks postoperatively

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited by the clinical investigators in the Hanusch Hospital. Each subject has to meet the inclusion and exclusion criteria and to sign informed consent.

You may qualify if:

• Cataract
• Age 21 and older
• Able to understand the patient information
• willing to follow the orders and coming to all follow-up visits
• willing to sign informed consent prior to surgery

You may not qualify if:

• Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
• Previous ocular surgeries on the study eye
• Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
• pregnant (pregnancy test will be taken preoperatively in women of reproductive age) or lactating women

Sponsors & Collaborators

• Prim. Prof. Dr. Oliver Findl, MBA: lead

Study Sites (1)

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Oliver Findl, Prof Dr

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prim. Prof. Dr. MBA

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: July 31, 2015
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

AU (1)