Compare ELP in Patients With Elective Phaco-VTX Surgery in One Eye and a Single Lens Phaco Surgery on the Other Eye

Macular Pucker Clinical Trial

— ELP  

Official title:

Vergelijking Van de Postoperatieve Effectieve Lenspositie (ELP) Bij patiënten Gepland Voor Een Electieve Phacovitrectomie-ingreep (Phaco-VTX) Aan één Oog en Enkel Een Lensingreep Phaco Aan Het Andere Oog

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397068
• Other study ID #: S58904
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to gain more insight into the potential impact of a vitrectomy (removal of the vitreous) on postoperative effective position of the intraocular lens (IOL). Moreover, this study can provide very useful information for the optimal lens calculation in patients undergoing lens extraction with IOL implantation (whether or not combined with a vitrectomy) should undergo.

Description:

• Comparison ELP post phaco VTX (pucker / floaters) versus post phaco and use this information to develop a customized IOL calculation for eyes undergoing phacoVTX.

• Evidence for recording lens thickness (LT) parameter in the IOL strength calculation in KWS (in the calculation of the ELP in the light of the Olsen formula, using the C-constant) in order to be able to make an even more accurate prediction of the post-operative diopter target of the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• age > 50 yrs

• macular pucker wherefore vitrectomy is necessary

Exclusion Criteria:

• macular pathology other than macular pucker

• Corneal pathology

• Other ocular pathology that could affect the biometrics or ELP

• Previous vitrectomy in one of the eyes

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Pucker

Intervention

Procedure:
• phaco-vitrectomy
phaco-vitrectomy. No other involvement drug or device. Standard of care procedure

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare if ELP is different or the same at phaco or phaco-vitrectomy	Anterior chamber depth measured using IOL master.	6 - 8 weeks