Phacoemulsification Cataract SurgeryCTR-IOL-3ARMNCT07842809
Capsular Tension Ring With Hydrophilic Versus Hydrophobic Intraocular Lenses
A study testing Hydrophilic acrylic intraocular lens (Eyecryl), Capsular tension ring (Auroring CTR 11) and Hydrophobic acrylic intraocular lens (AcrySof IQ) in people with Phacoemulsification Cataract Surgery and Capsular Tension Ring, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phacoemulsification Cataract Surgery, Capsular Tension Ring, IOL Implantation
- What is being tested?
- Hydrophilic acrylic intraocular lens (Eyecryl), Capsular tension ring (Auroring CTR 11) and Hydrophobic acrylic intraocular lens (AcrySof IQ)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 15 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous intraocular surgery
- Ocular trauma
- Pseudoexfoliation syndrome
- Posterior polar cataract
- Zonular instability
- Complicated cataract
Show all 9Show fewer
- Active intraocular inflammation
- Retinal or optic nerve pathology
- Anticipated need for additional capsular support devices beyond the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Hydrophilic Intraocular Lens Implantation With and Without a Capsular Tension Ring Versus Hydrophobic Intraocular Lens Implantation Alone: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Background and rationale: Phacoemulsification with intraocular lens (IOL) implantation is the standard treatment for age-related cataract. IOL material (hydrophilic versus hydrophobic acrylic) is a recognized determinant of long-term capsular biocompatibility, with hydrophobic acrylic lenses generally associated with lower rates of posterior capsule opacification (PCO) and reduced need for neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy compared with hydrophilic acrylic lenses. Capsular tension rings (CTRs) are polymethyl methacrylate devices that stabilize the capsular bag equator and have been proposed to mitigate capsular contraction, lens decentration, and PCO, independent of IOL material. Prior comparative work has generally examined either IOL material effects or CTR effects in isolation, or has compared a composite intervention (hydrophilic IOL plus CTR) against a hydrophobic IOL alone, without a design capable of isolating the CTR's independent contribution.
Objectives: To compare visual, refractive, anatomical (IOL position and posterior capsule opacification), and safety outcomes among three approaches to routine cataract surgery: (1) hydrophilic acrylic IOL implantation combined with a CTR (Group A); (2) hydrophobic acrylic IOL implantation alone (Group B); and (3) hydrophilic acrylic IOL implantation alone, without a CTR (Group C). The inclusion of Group C, using the same hydrophilic IOL model as Group A but without CTR insertion, was designed specifically to allow assessment of the CTR's independent contribution when compared against Group A, in addition to the material-based comparisons of Groups A and C against Group B.
Design: Prospective, randomized, parallel-group, three-arm controlled trial conducted at three tertiary ophthalmology centers in Egypt (Zagazig University Hospital, Benha University Hospital, and Al-Azhar University Hospital). Eligible adults aged 50-80 years with visually significant age-related cataract (LOCS III grade >=3) were randomized 1:1:1 using a computer-generated allocation sequence, with allocation concealment via sealed opaque envelopes opened intraoperatively. Outcome assessors and data analysts were blinded to treatment allocation; operating surgeons were not blinded due to the nature of the intervention.
Interventions: All participants underwent standardized phacoemulsification via a 2.2 mm clear corneal incision with a ~5.5 mm continuous curvilinear capsulorhexis. Group A received a hydrophilic acrylic IOL (Eyecryl, Biotech Healthcare, India) plus a polymethyl methacrylate CTR (Auroring CTR 11, Aurolab, India). Group B received a hydrophobic acrylic IOL (AcrySof IQ, Alcon Laboratories, USA) without a CTR. Group C received the same hydrophilic acrylic IOL as Group A, without CTR insertion.
Outcomes: Primary outcomes were best-corrected visual acuity (logMAR) and manifest spherical equivalent refractive error at 24 months, with longitudinal assessment at 1, 3, 6, 12, 18, and 24 months. Secondary outcomes included posterior capsule opacification grade (slit-lamp retroillumination, graded per Aslam et al.), Nd:YAG capsulotomy rate, IOL centration and tilt (anterior segment optical coherence tomography), and intraoperative and postoperative complications (posterior capsule rupture, zonular dialysis, vitreous loss, iris trauma, cystoid macular edema, intraocular pressure elevation, corneal edema, and endophthalmitis).
Follow-up: Scheduled visits at day 1, week 1, and months 1, 3, 6, 12, 18, and 24 postoperatively, with the 24-month visit representing the final prespecified assessment.
Statistical analysis: Continuous variables were compared across groups using one-way ANOVA or Kruskal-Wallis testing as appropriate, with post-hoc pairwise comparisons for Group A vs. Group B and Group C vs. Group B. Categorical variables were compared using chi-square or Fisher's exact test. Repeated-measures ANOVA assessed longitudinal group x time interactions for visual and refractive outcomes.
- Being tested
- Hydrophilic acrylic intraocular lens (Eyecryl), Capsular tension ring (Auroring CTR 11), Hydrophobic acrylic intraocular lens (AcrySof IQ)
- Keywords
- Capsular tension ring, Cataract surgery, Phacoemulsification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophilic acrylic intraocular lens (Eyecryl)Device
Foldable hydrophilic acrylic intraocular lens implanted in the capsular bag following phacoemulsification.
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.
Hydrophobic acrylic intraocular lens (AcrySof IQ)Device
Foldable hydrophobic acrylic intraocular lens implanted in the capsular bag following phacoemulsification.
| Study group | Role | What they receive |
|---|---|---|
| U.S. flag An official website of the United States government Here's how you know Skip to main page | 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). Receives: 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. Receives: 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. Receives: Device: Hydrophilic acrylic intraocular lens (Eyecryl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months postoperatively
Secondary outcomes (1)
Manifest spherical equivalent refractive error
Manifest spherical equivalent refractive error (diopters), assessed longitudinally at 1, 3, 6, 12, 18, and 24 months, with between-group comparison at 24 months as the primary efficacy endpoint. Proportion of eyes within +/-0.5 D and +/-1.0 D of target refraction was also assessed at 24 months.
Measured: 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Dec 2022
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phacoemulsification Cataract SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, parallel-group, randomized controlled trial comparing hydrophilic acrylic IOL plus capsular tension ring, hydrophobic acrylic IOL alone, and hydrophilic acrylic IOL alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 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
- NCT07842809
- Sponsor's protocol ID
- ZU-BU-AU-CTR-IOL-3ARM-2023
- Acronym
- CTR-IOL-3ARM
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Hydrophilic Intraocular Lens Implantation With and Without a Capsular Tension Ring Versus Hydrophobic Intraocular Lens Implantation Alone: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07842809
- Acronym / sponsor ID
- CTR-IOL-3ARM / ZU-BU-AU-CTR-IOL-3ARM-2023
- Keywords
- Capsular tension ring, Cataract surgery, Phacoemulsification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 25 Sep 2026 (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.
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.
Detailed description
Background and rationale: Phacoemulsification with intraocular lens (IOL) implantation is the standard treatment for age-related cataract. IOL material (hydrophilic versus hydrophobic acrylic) is a recognized determinant of long-term capsular biocompatibility, with hydrophobic acrylic lenses generally associated with lower rates of posterior capsule opacification (PCO) and reduced need for neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy compared with hydrophilic acrylic lenses. Capsular tension rings (CTRs) are polymethyl methacrylate devices that stabilize the capsular bag equator and have been proposed to mitigate capsular contraction, lens decentration, and PCO, independent of IOL material. Prior comparative work has generally examined either IOL material effects or CTR effects in isolation, or has compared a composite intervention (hydrophilic IOL plus CTR) against a hydrophobic IOL alone, without a design capable of isolating the CTR's independent contribution.
Objectives: To compare visual, refractive, anatomical (IOL position and posterior capsule opacification), and safety outcomes among three approaches to routine cataract surgery: (1) hydrophilic acrylic IOL implantation combined with a CTR (Group A); (2) hydrophobic acrylic IOL implantation alone (Group B); and (3) hydrophilic acrylic IOL implantation alone, without a CTR (Group C). The inclusion of Group C, using the same hydrophilic IOL model as Group A but without CTR insertion, was designed specifically to allow assessment of the CTR's independent contribution when compared against Group A, in addition to the material-based comparisons of Groups A and C against Group B.
Design: Prospective, randomized, parallel-group, three-arm controlled trial conducted at three tertiary ophthalmology centers in Egypt (Zagazig University Hospital, Benha University Hospital, and Al-Azhar University Hospital). Eligible adults aged 50-80 years with visually significant age-related cataract (LOCS III grade >=3) were randomized 1:1:1 using a computer-generated allocation sequence, with allocation concealment via sealed opaque envelopes opened intraoperatively. Outcome assessors and data analysts were blinded to treatment allocation; operating surgeons were not blinded due to the nature of the intervention.
Interventions: All participants underwent standardized phacoemulsification via a 2.2 mm clear corneal incision with a ~5.5 mm continuous curvilinear capsulorhexis. Group A received a hydrophilic acrylic IOL (Eyecryl, Biotech Healthcare, India) plus a polymethyl methacrylate CTR (Auroring CTR 11, Aurolab, India). Group B received a hydrophobic acrylic IOL (AcrySof IQ, Alcon Laboratories, USA) without a CTR. Group C received the same hydrophilic acrylic IOL as Group A, without CTR insertion.
Outcomes: Primary outcomes were best-corrected visual acuity (logMAR) and manifest spherical equivalent refractive error at 24 months, with longitudinal assessment at 1, 3, 6, 12, 18, and 24 months. Secondary outcomes included posterior capsule opacification grade (slit-lamp retroillumination, graded per Aslam et al.), Nd:YAG capsulotomy rate, IOL centration and tilt (anterior segment optical coherence tomography), and intraoperative and postoperative complications (posterior capsule rupture, zonular dialysis, vitreous loss, iris trauma, cystoid macular edema, intraocular pressure elevation, corneal edema, and endophthalmitis).
Follow-up: Scheduled visits at day 1, week 1, and months 1, 3, 6, 12, 18, and 24 postoperatively, with the 24-month visit representing the final prespecified assessment.
Statistical analysis: Continuous variables were compared across groups using one-way ANOVA or Kruskal-Wallis testing as appropriate, with post-hoc pairwise comparisons for Group A vs. Group B and Group C vs. Group B. Categorical variables were compared using chi-square or Fisher's exact test. Repeated-measures ANOVA assessed longitudinal group x time interactions for visual and refractive outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group, randomized controlled trial comparing hydrophilic acrylic IOL plus capsular tension ring, hydrophobic acrylic IOL alone, and hydrophilic acrylic IOL alone.
| Arm | Type | Receives |
|---|---|---|
| U.S. flag An official website of the United States government Here's how you know Skip to main page | Experimental | Device: Hydrophilic acrylic intraocular lens (Eyecryl), Device: Capsular tension ring (Auroring CTR 11)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). |
| Group B: Hydrophobic IOL alone | Active comparator | Device: Hydrophobic acrylic intraocular lens (AcrySof IQ)Phacoemulsification with implantation of a hydrophobic acrylic intraocular lens (AcrySof IQ, Alcon Laboratories, USA), without a capsular tension ring. |
| Group C: Hydrophilic IOL alone | Experimental | Device: Hydrophilic acrylic intraocular lens (Eyecryl)Phacoemulsification with implantation of the same hydrophilic acrylic intraocular lens used in Group A (Eyecryl, Biotech Healthcare, India), without capsular tension ring insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Previous intraocular surgery
- Ocular trauma
- Pseudoexfoliation syndrome
- Posterior polar cataract
- Zonular instability
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 |
|---|---|---|
| Hydrophilic acrylic intraocular lens (Eyecryl)Foldable hydrophilic acrylic intraocular lens implanted in the capsular bag following phacoemulsification. | Device | 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)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. | Device | U.S. flag An official website of the United States government Here's how you know Skip to main page |
| Hydrophobic acrylic intraocular lens (AcrySof IQ)Foldable hydrophobic acrylic intraocular lens implanted in the capsular bag following phacoemulsification. | Device | Group B: Hydrophobic IOL alone |
Primary outcome
Best-corrected visual acuity (BCVA)
Time frame: 24 months postoperatively
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.
1 secondary outcome
Manifest spherical equivalent refractive error
Time frame: 24 months postoperatively
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 25 Sep 2026.
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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 Hydrophilic acrylic intraocular lens (Eyecryl), Capsular tension ring (Auroring CTR 11) and Hydrophobic acrylic intraocular lens (AcrySof IQ) in people with Phacoemulsification Cataract Surgery and Capsular Tension Ring, 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 6 inclusion and 9 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 25 Sep 2026. 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?
Best-corrected visual acuity (BCVA) (time frame: 24 months postoperatively). 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 25 Sep 2026.