Capsular Tension Ring With Hydrophilic Versus Hydrophobic Intraocular Lenses

NCT07842809 | Completed

• 1 other identifier: ZU-BU-AU-CTR-IOL-3ARM-2023
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares three approaches to cataract surgery. Cataract surgery involves removing the eye's cloudy natural lens and replacing it with an artificial intraocular lens (IOL) to restore clear vision. IOLs are made from different materials, most commonly a "hydrophilic" (water-attracting) acrylic or a "hydrophobic" (water-repelling) acrylic. Hydrophilic lenses are generally easier and less expensive to use, but have been linked in past research to a higher chance of the lens capsule becoming cloudy again after surgery (posterior capsule opacification, or PCO), sometimes requiring a follow-up laser treatment. Hydrophobic lenses tend to have lower rates of this problem but can cost more. A capsular tension ring (CTR) is a small flexible ring that can be placed inside the eye at the time of surgery to help hold the lens capsule in a stable, round shape. This study asks whether adding a CTR when a hydrophilic lens is used can reduce the disadvantages usually seen with that lens material. 600 adult patients (ages 50-80) undergoing cataract surgery at three hospitals in Egypt were randomly assigned to one of three groups: (1) a hydrophilic lens plus a CTR, (2) a hydrophobic lens alone (the common comparison approach), or (3) a hydrophilic lens alone without a CTR. Patients were followed for 24 months, and researchers compared vision, glasses prescription accuracy, lens position, capsule clouding, need for laser treatment, and surgical complications between the groups. The results showed that adding a CTR to a hydrophilic lens produced results very similar to using a hydrophobic lens alone. In contrast, using a hydrophilic lens without a CTR resulted in worse vision, less accurate glasses prescriptions, more lens shifting or tilting, more capsule clouding, a higher need for laser treatment, and more complications compared with the hydrophobic lens. These findings suggest that adding a CTR may be a simple, low-cost way to improve outcomes when a hydrophilic lens is used for cataract surgery.

Conditions

Phacoemulsification Cataract Surgery; Capsular Tension Ring; IOL Implantation

Keywords

Capsular tension ring; Cataract surgery; Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• Best-corrected visual acuity (BCVA)

  Best-corrected visual acuity measured in logMAR units, assessed longitudinally at 1, 3, 6, 12, 18, and 24 months, with between-group comparison at 24 months as the primary efficacy endpoint.

  24 months postoperatively

Secondary Outcomes (1)

• Manifest spherical equivalent refractive error

  24 months postoperatively

Study Arms (3)

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EXPERIMENTAL

Phacoemulsification with implantation of a hydrophilic acrylic intraocular lens (Eyecryl, Biotech Healthcare, India) combined with insertion of a polymethyl methacrylate capsular tension ring (Auroring CTR 11, Aurolab, India).

Device: Hydrophilic acrylic intraocular lens (Eyecryl); Device: Capsular tension ring (Auroring CTR 11)

Group B: Hydrophobic IOL alone

ACTIVE COMPARATOR

Phacoemulsification with implantation of a hydrophobic acrylic intraocular lens (AcrySof IQ, Alcon Laboratories, USA), without a capsular tension ring.

Device: Hydrophobic acrylic intraocular lens (AcrySof IQ)

Group C: Hydrophilic IOL alone

EXPERIMENTAL

Phacoemulsification with implantation of the same hydrophilic acrylic intraocular lens used in Group A (Eyecryl, Biotech Healthcare, India), without capsular tension ring insertion.

Device: Hydrophilic acrylic intraocular lens (Eyecryl)

Interventions

Hydrophilic acrylic intraocular lens (Eyecryl) DEVICE

Foldable hydrophilic acrylic intraocular lens implanted in the capsular bag following phacoemulsification.

Group C: Hydrophilic IOL alone; U.S. flag An official website of the United States government Here's how you know Skip to main page

Capsular tension ring (Auroring CTR 11) DEVICE

Polymethyl methacrylate capsular tension ring (overall diameter 13.0 mm, compressed diameter 11.0 mm) inserted into the capsular bag to distribute equatorial zonular forces and maintain capsular bag contour.

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Hydrophobic acrylic intraocular lens (AcrySof IQ) DEVICE

Foldable hydrophobic acrylic intraocular lens implanted in the capsular bag following phacoemulsification.

Group B: Hydrophobic IOL alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-80 years
• Visually significant age-related cataract, defined as nuclear opacity grade \>=3 according to the Lens Opacities Classification System III (LOCS III), graded preoperatively under standardized mydriasis via slit-lamp biomicroscopy
• Clear cornea
• Adequate pupillary dilation
• Anatomically normal capsular bag with no evidence of zonular weakness
• No ocular comorbidities expected to affect visual or refractive outcomes

You may not qualify if:

• Previous intraocular surgery
• Ocular trauma
• Pseudoexfoliation syndrome
• Posterior polar cataract
• Zonular instability
• Complicated cataract
• Active intraocular inflammation
• Retinal or optic nerve pathology
• Anticipated need for additional capsular support devices beyond the study protocol

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts were blinded to treatment allocation. Operating surgeons could not be masked due to the nature of the surgical intervention (visible IOL material and presence/absence of a capsular tension ring during implantation).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Model Details: Three-arm, parallel-group, randomized controlled trial comparing hydrophilic acrylic IOL plus capsular tension ring, hydrophobic acrylic IOL alone, and hydrophilic acrylic IOL alone.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: December 15, 2022
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

EG (1)