Objective Measurements of the Opacification of the Lens After Vitrectomy

Not Applicable

Completed

• Conditions: Vitrectomy; Cataract
• Interventions: Procedure: Objective Scatter Index (OSI); Procedure: Average Lens Density (ALD)

• Registration Number: NCT04566237
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study Start: 2020-09-21
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-28
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
24 months follow up after vitrectomy	Objective Scatter Index (OSI)	Objective Scatter Index (OSI) and Average Lens Density (ALD) at inclusion, then 3 months, 12 months and 24 months after vitrectomy
24 months follow up after vitrectomy	Average Lens Density (ALD)	Objective Scatter Index (OSI) and Average Lens Density (ALD) at inclusion, then 3 months, 12 months and 24 months after vitrectomy

Primary Outcome Measures

Name	Time	Method
Change in ALD value between baseline and 12 months after the intervention	Baseline and 12 months after vitrectomy	ALD value : quantitative variable expressed in pixel units

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschuld; 🇫🇷 Paris, France