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OpenTrials
Completed

NCT Number: NCT04566237

Objective Measurements of the Opacification of the Lens After Vitrectomy

Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years.

In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication.

The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units.

Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group.

To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient over 18 years old
  • Indication for unilateral 3-way vitrectomy for retinal detachment, macular hole, epiretinal membrane, vitreous hemorrhage
  • Bilateral phakic patient

Exclusion criteria

  • Vitrectomy combined with cataract surgery
  • Pregnant or breastfeeding woman

Treatment and study plan

Objective Scatter Index (OSI)

Procedure

On Optical Quality Analysis System (OQAS) device. At Inclusion, 3 months, 12 months and 24 months after vitrectomy

Average Lens Density (ALD)

Procedure

on IOLMaster® 700 device. At Inclusion, 3 months, 12 months and 24 months after vitrectomy

Primary outcomes

  1. Change in ALD value between baseline and 12 months after the intervention

    Time frame: Baseline and 12 months after vitrectomy

    ALD value : quantitative variable expressed in pixel units

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: MOCVIT

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2020
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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