Quality of vision of patients implanted with intraocular lens after cataract surgery

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001319460
• Date of registration: 21/09/2016
• Prospective Registration: Yes
• Primary sponsor: ClarVista Medical, Inc.
• Public title: Quality of vision of patients implanted with intraocular lens after cataract surgery
• Scientific title: Quality of vision of patients implanted with intraocular lens after cataract surgery
• Date of first enrolment: 01/10/2016
• Target sample size: 100
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616001319460.aspx
• Study type: Observational
• Phase: Not Applicable

Countries of recruitment

New Zealand, Philippines

Contacts

• Name: Dr Melvin Sarayba

• Name: Dr Melvin Sarayba

Key inclusion & exclusion criteria

Inclusion criteria: 1. Must have had cataract removal and intraocular lens implantation at least 3 months prior.
2. Must be willing to answer the questionnaire
Exclusion criteria: Subject who, in the clinical judgment of the investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator

Age minimum: 22 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Quality of Vision after cataract removal and intraocular lens implantation;
Quality of Vision after cataract removal and intraocular lens implantation

Eye - Diseases / disorders of the eye

Intervention(s)

This is a patient reported outcome study using a validated questionnaire as instrument. Patients have had cataract removal and intraocular lens implantation (these include any commercially available models used at the study recruitment sites) at least 3 months prior. Patients will be asked to observe their vision quality for 1 week and answer questions that provided to them by the questionnaire.

Primary Outcome(s)

The Quality of Vision (QoV) questionnaire is a validated Patient Reported Outcome (PRO) instrument. It consists of 10 questions on different types of visual disturbances (e.g. blurring, haloes, double vision, etc.). Each item has 3 corresponding questions regarding the Frequency, Severity and Bothersome, resulting in a 30-item questionnaire.


[The instrument will be presented and explained to the subjects at minimum of 3 months after cataract removal and intraocular lens implantation surgery. They will then be send home with the questionnaire. They will be asked to return to the clinic 1 week after and the questionnaire will be administered at the clinic by the study staff for 3 times. First for the left eye, second for the right eye and third for binocular experience. After this visit, it is considered that patient completed the study.]

The QoV measures positive dysphotopsia but not negative dysphotopsia which is pertinent to any IOL study. A separate part of questionnaire composed of 3 questions will be used to measure negative dysphotopsia." These 3 questions have been designed specifically for this study.[The instrument will be presented and explained to the subjects at minimum of 3 months after cataract removal and intraocular lens implantation surgery. They will then be send home with the questionnaire. They will be asked to return to the clinic 1 week after and the questionnaire will be administered at the clinic by the study staff for 3 times. First for the left eye, second for the right eye and third for binocular experience. After this visit, it is considered that patient completed the study.]

Secondary Outcome(s)

None[None]

Secondary ID(s)

None

Source(s) of Monetary Support

ClarVista Medical, Inc.

Ethics review

Status: Not approved
Approval date:
Contact:

HDEC