Objective Measurements of the Opacification of the Lens After Vitrectomy

NCT04566237 | Completed

• 1 other identifier: RLX_2020_26
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitrectomy; Cataract

Keywords

Objective Scatter Index (OSI); Optical Quality Analysis System (OQAS); Average Lens Density (ALD); IOLMaster® 700

Outcome Measures

Primary Outcomes (1)

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

  ALD value : quantitative variable expressed in pixel units

  Baseline and 12 months after vitrectomy

Study Arms (1)

24 months follow up after vitrectomy

EXPERIMENTAL

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

Procedure: Objective Scatter Index (OSI); Procedure: Average Lens Density (ALD)

Interventions

Objective Scatter Index (OSI) PROCEDURE

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

24 months follow up after vitrectomy

Average Lens Density (ALD) PROCEDURE

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

24 months follow up after vitrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Vitrectomy combined with cataract surgery
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Raphaël LEJOYEUX, MD

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 28, 2020
• Study Start: September 21, 2020
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)