Intraocular Lens ComplicationNCT06974578
Capsular Tension Ring With Hydeophilic Intraocular Lesnes to Decrease Posterior Capsule Opacification Versus Hydrophobic Ones
A study testing phacoemulsification, CTR and hydrophilic IOL in people with Intraocular Lens Complication, run by Benha University at 1 site in Egypt.
Trial summary
evaluate the clinical outcomes of routine CTR insertion in conjunction with hydrophilic versus hydrophobic IOLs following phacoemulsification. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Intraocular Lens Complication
- What is being tested?
- phacoemulsification, CTR and hydrophilic IOL
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Feb 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Adults aged 40-80 years.
- Visually significant cataract (≥3+ on Lens Opacities Classification System III "LOCSIII").
- Clear cornea.
Who cannot join
- • Previous ocular surgery.
- Zonular instability requiring CTR insertion beyond routine practice.
- Complicated cataract cases (e.g., traumatic cataract).
- Active intraocular inflammation or infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Intraocular Lens Complication
- Being tested
- phacoemulsification, CTR, hydrophilic IOL, Hydrophobic IOL
- Keywords
- CTR, IOLs, Phacoemulsification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationProcedure or surgery
cataract extracton with phacoemulsification
CTRDevice
insertion of capsualr tension ring
hydrophilic IOLDevice
implantation of hydrophilic IOL
Hydrophobic IOLDevice
insertion of hydrophobic IOL
| Study group | Role | What they receive |
|---|---|---|
| Group A: CTR + Hydrophilic IOL | Active comparator | phacoemulsification and insertion of CTR the hydrophilic IOL Receives: Procedure: phacoemulsification; Device: CTR; Device: hydrophilic IOL |
| Group B: Hydrophobic IOL alone | Active comparator | phacoemulsification and insertiion of hydrophobic IOL Receives: Procedure: phacoemulsification; Device: Hydrophobic IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at 1, 3, and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 Feb 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Lens ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974578
- Sponsor's protocol ID
- CTR with IOL
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Outcomes of Routine Insertion of Capsular Tension Ring (CTR) With Hydrophilic Versus Hydrophobic Intraocular Lenses (IOLs) Alone After Phacoemulsification
- ClinicalTrials.gov ID
- NCT06974578
- Acronym / sponsor ID
- CTR with IOL
- Conditions
- Intraocular Lens Complication
- Keywords
- CTR, IOLs, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
evaluate the clinical outcomes of routine CTR insertion in conjunction with hydrophilic versus hydrophobic IOLs following phacoemulsification.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: CTR + Hydrophilic IOL | Active comparator | Procedure: phacoemulsification, Device: CTR, Device: hydrophilic IOLphacoemulsification and insertion of CTR the hydrophilic IOL |
| Group B: Hydrophobic IOL alone | Active comparator | Procedure: phacoemulsification, Device: Hydrophobic IOLphacoemulsification and insertiion of hydrophobic IOL |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Adults aged 40-80 years.
Key exclusion criteria (4 listed)
- • Previous ocular surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phacoemulsificationcataract extracton with phacoemulsification | Procedure or surgery | Group A: CTR + Hydrophilic IOL, Group B: Hydrophobic IOL alone |
| CTRinsertion of capsualr tension ring | Device | Group A: CTR + Hydrophilic IOL |
| hydrophilic IOLimplantation of hydrophilic IOL | Device | Group A: CTR + Hydrophilic IOL |
| Hydrophobic IOLinsertion of hydrophobic IOL | Device | Group B: Hydrophobic IOL alone |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification, CTR and hydrophilic IOL in people with Intraocular Lens Complication, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BCVA (LogMAR) (time frame: at 1, 3, and 6 months postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.