Capsular Tension Ring With Hydeophilic Intraocular Lesnes to Decrease Posterior Capsule Opacification Versus Hydrophobic Ones

NCT ID: NCT06974578

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2024-09-01

Brief Summary

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evaluate the clinical outcomes of routine CTR insertion in conjunction with hydrophilic versus hydrophobic IOLs following phacoemulsification.

Detailed Description

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Phacoemulsification with intraocular lens (IOL) implantation is the standard surgical approach for cataract extraction. The choice between hydrophilic and hydrophobic IOLs has been debated, with studies suggesting differences in posterior capsule opacification (PCO) rates and capsular bag stability. Capsular tension rings (CTRs) are devices designed to stabilize the capsular bag, particularly in cases with zonular weakness. While CTRs are beneficial in complex cases, their routine use remains controversial. Understanding the interaction between CTRs and IOL materials could inform surgical practices and improve patient outcomes

Conditions

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Intraocular Lens Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A: CTR + Hydrophilic IOL

phacoemulsification and insertion of CTR the hydrophilic IOL

Group Type ACTIVE_COMPARATOR

phacoemulsification

Intervention Type PROCEDURE

cataract extracton with phacoemulsification

CTR

Intervention Type DEVICE

insertion of capsualr tension ring

hydrophilic IOL

Intervention Type DEVICE

implantation of hydrophilic IOL

Group B: Hydrophobic IOL alone

phacoemulsification and insertiion of hydrophobic IOL

Group Type ACTIVE_COMPARATOR

phacoemulsification

Intervention Type PROCEDURE

cataract extracton with phacoemulsification

Hydrophobic IOL

Intervention Type DEVICE

insertion of hydrophobic IOL

Interventions

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phacoemulsification

cataract extracton with phacoemulsification

Intervention Type PROCEDURE

CTR

insertion of capsualr tension ring

Intervention Type DEVICE

hydrophilic IOL

implantation of hydrophilic IOL

Intervention Type DEVICE

Hydrophobic IOL

insertion of hydrophobic IOL

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Adults aged 40-80 years.

* Visually significant cataract (≥3+ on Lens Opacities Classification System III "LOCSIII").
* Clear cornea.

Exclusion Criteria

* • Previous ocular surgery.

* Zonular instability requiring CTR insertion beyond routine practice.
* Complicated cataract cases (e.g., traumatic cataract).
* Active intraocular inflammation or infection.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ehab Mohamed Elsayed Mohamed Saad

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar Faculty of Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CTR with IOL

Identifier Type: -

Identifier Source: org_study_id

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