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

NCT06974578 | Completed DMC

• 1 other identifier: CTR with IOL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraocular Lens Complication

Keywords

CTR; IOLs; Phacoemulsification

Outcome Measures

Primary Outcomes (2)

• Change in BCVA (LogMAR)

  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)

  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.

Study Arms (2)

Group A: CTR + Hydrophilic IOL

ACTIVE COMPARATOR

phacoemulsification and insertion of CTR the hydrophilic IOL

Procedure: phacoemulsification; Device: CTR; Device: hydrophilic IOL

Group B: Hydrophobic IOL alone

ACTIVE COMPARATOR

phacoemulsification and insertiion of hydrophobic IOL

Procedure: phacoemulsification; Device: Hydrophobic IOL

Interventions

phacoemulsification PROCEDURE

cataract extracton with phacoemulsification

Group A: CTR + Hydrophilic IOL; Group B: Hydrophobic IOL alone

CTR DEVICE

insertion of capsualr tension ring

Group A: CTR + Hydrophilic IOL

hydrophilic IOL DEVICE

implantation of hydrophilic IOL

Group A: CTR + Hydrophilic IOL

Hydrophobic IOL DEVICE

insertion of hydrophobic IOL

Group B: Hydrophobic IOL alone

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 40-80 years.
• Visually significant cataract (≥3+ on Lens Opacities Classification System III "LOCSIII").
• Clear cornea.

You may not qualify if:

• Previous ocular surgery.
• Zonular instability requiring CTR insertion beyond routine practice.
• Complicated cataract cases (e.g., traumatic cataract).
• Active intraocular inflammation or infection.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Al-Azhar Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: February 8, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

EG (1)