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OpenTrials
Completed

NCT Number: NCT06974578

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

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

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Key information

Conditions

Intraocular Lens Complication

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar Faculty of Medicine

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

phacoemulsification

Procedure

cataract extracton with phacoemulsification

CTR

Device

insertion of capsualr tension ring

hydrophilic IOL

Device

implantation of hydrophilic IOL

Hydrophobic IOL

Device

insertion of hydrophobic IOL

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2025
Registry last updated
May 16, 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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