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

May 8, 2025 updated by: Ehab Mohamed Elsayed Mohamed Saad, Benha University

Assessment of the Outcomes of Routine Insertion of Capsular Tension Ring (CTR) With Hydrophilic Versus Hydrophobic Intraocular Lenses (IOLs) Alone After Phacoemulsification

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Al-Azhar Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: CTR + Hydrophilic IOL
phacoemulsification and insertion of CTR the hydrophilic IOL
Procedure: phacoemulsification
cataract extracton with phacoemulsification
Device: CTR
insertion of capsualr tension ring
Device: hydrophilic IOL
implantation of hydrophilic IOL
Active Comparator: Group B: Hydrophobic IOL alone
phacoemulsification and insertiion of hydrophobic IOL
Procedure: phacoemulsification
cataract extracton with phacoemulsification
Device: Hydrophobic IOL
insertion of hydrophobic IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BCVA (LogMAR)
Time Frame: at 1, 3, and 6 months postoperatively.
The formula: logMAR score (0.1 NL + 0.02 nl) where NL = number of lines completely read and nl = number of additional letters read ap- plies. For this method, the higher the logMAR VA score, the better the visual acuity.
at 1, 3, and 6 months postoperatively.
Refractive error measurements (spherical equivalent)
Time Frame: at 1, 3, and 6 months postoperatively.
SE was calculated as the spherical power of the refractive error plus one-half of the cylinder power. Hyperopia was defined as a spherical equivalent (SE) values of ≥ + 1.00 diopter (D) and emmetropia as a SE ranging between 0.99 and - 0.49 D. Myopia was defined as a SE refraction of ≤ -0.50 D.
at 1, 3, and 6 months postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

May 8, 2025

First Submitted That Met QC Criteria

May 8, 2025

First Posted (Actual)

May 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTR with IOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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