MyopiaNCT04624035
Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens
A study testing Implantable Collamer Lens (ICL) in treatment of myopia in adults. and Implantable Intraocular Lens (IPCL) in treatment of myopia in adults. in people with Myopia, run by Assiut University at 2 sites in Egypt.
Trial summary
Phakic intraocular lenses (pIOL) of different designs and materials have been used effectively instead of corneal refractive surgery in certain situations. The pIOL exhibits a number of advantages over corneal techniques as it is suitable for high myopes, with lower production of aberrations, and superior contrast… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Implantable Collamer Lens (ICL) in treatment of myopia in adults. and Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Oct 2020to Oct 2021
- 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
- myopia of more than 6 diopter
- central anterior chamber depth more than 2.8 mm
Who cannot join
- unstable refraction
- any other ocular disease
- any systemic disease
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Tiba eye center
Asyut
Mahmoud Rateb, PhD
- Recruiting
Al Masa eye center
Banhā
Mohamed ElMohamady, MD
About this study
Official title: Comparison Between Implantable Phakic Intraocular Lens and Implantable Collamer Lens in Treatment of Myopia in Adults
Phakic intraocular lenses (pIOL) of different designs and materials have been used effectively instead of corneal refractive surgery in certain situations. The pIOL exhibits a number of advantages over corneal techniques as it is suitable for high myopes, with lower production of aberrations, and superior contrast sensitivity. Keeping the accommodation is its definite lead over refractive lens exchange. The Visian implantable collamer lens (ICL; Staar Surgical, Monrovia, CA), a posterior chamber pIOL, has been stated to be useful for the correction of high myopia. Nevertheless, as an intraocular procedure, it is associated with a risk of complications as probable injury to anterior segment, retinal detachment and endophthalmitis.
The Implantable Phakic Contact Lens (IPCL V2, Caregroup Sight Solutions, India) has been developed as an alternative for the ICL, at a noticeable financial advantage. Furthermore, the highestmyopic correction which is instantly accessible with ICL is -18.0 D. Meanwhile, IPCL can provide correction higher degrees up to -30.0 D.
Former researches have been made to assess the safety and efficiency of ICL implantation, to evaluate various devices for anterior segment imaging postoperatively and to identify changes in anterior segment after surgery. A recent study determined the safety of the IPCL over a minimum follow-up period of one year. In this work the investigators aimed to compare the refractive results and the adverse effects of the IPCL and the ICL in treatment of myopia in adults.
- Conditions
- Myopia
- Being tested
- Implantable Collamer Lens (ICL) in treatment of myopia in adults., Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Collamer Lens (ICL) in treatment of myopia in adults.Procedure or surgery
Also called All drugs used were mentioned in the arm description
ICL Group: After mydriatic eye drops and topical anesthesia instillation, a 3-mm temporal corneal incision was done. Viscoelastic material was injected in the anterior chamber (AC). An injector cartridge (STAAR Surgical) was used to insert the ICL V4c model with central hole). The four footplates of the ICL were positioned on the ciliary sulcus at the 180° axis. Viscoelastic material was entirely taken away.
Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.Procedure or surgery
Also called All drugs used were mentioned in the arm description
IPCL Group: Topical anesthetic and mydriatic agents were instilled before surgery. Using peripulbar anaesthesia, the IPCL (V2 model with central hole) was implanted into the AC through a 3 mm clear corneal incision after viscoelastic material injection. The footplates were subsequently tucked behind the iris, followed by a thorough viscoelastic removal.
| Study group | Role | What they receive |
|---|---|---|
| Implantable Collamer Lens (ICL, V4c with central hole) in treatment of myopia in adults. | Active comparator | Implantation of ICL (V4c with central hole) for treatment of myopia in adults using peribulbar anesthesia. Thirty minutes before surgery, cycloplegic and phenylephrine eye drops were applied. Five minutes before surgery, povidone-iodine 5% was applied. The anterior chamber was filled with sodium hyaluronate 1%, which was completely removed at the end of the surgery. The lens was inserted using the ICL injector. Tobramycin and dexamethasone 0.1% eye drops were used four times a day for 10 days, after which diclofenac sodium eye drops were started four times a day for 2 weeks. Receives: Procedure: Implantable Collamer Lens (ICL) in treatment of myopia in adults. |
| Acrylic Implantable Intraocular Lens (IPCL, V2) in treatment of myopia in adults | Active comparator | Implantation of IPCL for treatment of Myopia in adults using peribulbar anesthesia. Thirty minutes before surgery, cycloplegic and phenylephrine eye drops were applied. Five minutes before surgery, povidone-iodine 5% was applied. The anterior chamber was filled with sodium hyaluronate 1%, which was completely removed at the end of the surgery. The lens was inserted using the IPCL injector. Tobramycin and dexamethasone 0.1% eye drops were used four times a day for 10 days, after which diclofenac sodium eye drops were started four times a day for 2 weeks. Receives: Procedure: Implantable Intraocular Lens (IPCL) in treatment of myopia in adults. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive outcome
Postoperative refractive error measured in spherical equivalent
Measured: 12 months
Visual outcome
Uncorrected distance and near vision using Snellen's chart and using decimal fractions
Measured: 12 months
Secondary outcomes (1)
Adverse reactions
adverse reactions will be recorded including intraocular inflammation, corneal endothelial changes and lens opactification
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start10 Oct 2020
- Primary completionJan 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud F. Rateb, Assiut University
- Investigators
- Mahmoud F Rateb, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624035
- Sponsor's protocol ID
- ICL vs IPCL
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data that underline the results of this trial will be available once completion of the study after de-identification.
Publications
Stulting RD, John ME, Maloney RK, Assil KK, Arrowsmith PN, Thompson VM; U.S. Verisyse Study Group. Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial. Ophthalmology. 2008 Mar;115(3):464-472.e1. doi: 10.1016/j.ophtha.2007.08.039. Epub 2007 Nov 26.
PubMed 18031820Kamiya K, Igarashi A, Shimizu K, Matsumura K, Komatsu M. Visual performance after posterior chamber phakic intraocular lens implantation and wavefront-guided laser in situ keratomileusis for low to moderate myopia. Am J Ophthalmol. 2012 Jun;153(6):1178-86.e1. doi: 10.1016/j.ajo.2011.12.005. Epub 2012 Feb 23.
PubMed 22365084Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.
PubMed 17172886Igarashi A, Kamiya K, Shimizu K, Komatsu M. Visual performance after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis for high myopia. Am J Ophthalmol. 2009 Jul;148(1):164-70.e1. doi: 10.1016/j.ajo.2009.02.001. Epub 2009 Apr 17.
PubMed 19375059Pineda-Fernandez A, Jaramillo J, Vargas J, Jaramillo M, Jaramillo J, Galindez A. Phakic posterior chamber intraocular lens for high myopia. J Cataract Refract Surg. 2004 Nov;30(11):2277-83. doi: 10.1016/j.jcrs.2004.03.035.
PubMed 15519075Elmohamady MN, Abdelghaffar W. Anterior Chamber Changes After Implantable Collamer Lens Implantation in High Myopia Using Pentacam: A Prospective Study. Ophthalmol Ther. 2017 Dec;6(2):343-349. doi: 10.1007/s40123-017-0109-3. Epub 2017 Sep 20.
PubMed 28933042Fernandes P, Gonzalez-Meijome JM, Madrid-Costa D, Ferrer-Blasco T, Jorge J, Montes-Mico R. Implantable collamer posterior chamber intraocular lenses: a review of potential complications. J Refract Surg. 2011 Oct;27(10):765-76. doi: 10.3928/1081597X-20110617-01. Epub 2011 Jun 30.
PubMed 21710954Sachdev G, Ramamurthy D. Long-term safety of posterior chamber implantable phakic contact lens for the correction of myopia. Clin Ophthalmol. 2019 Jan 7;13:137-142. doi: 10.2147/OPTH.S185304. eCollection 2019.
PubMed 30662257Zhang J, Luo HH, Zhuang J, Yu KM. Comparison of anterior section parameters using anterior segment optical coherence tomography and ultrasound biomicroscopy in myopic patients after ICL implantation. Int J Ophthalmol. 2016 Jan 18;9(1):58-62. doi: 10.18240/ijo.2016.01.10. eCollection 2016.
PubMed 26949611Rateb M, Gad AAM, Tohamy D, Elmohamady MN. A Prospective Comparative Study between Implantable Phakic Intraocular Contact Lens and Implantable Collamer Lens in Treatment of Myopia in Adults. J Ophthalmol. 2022 Mar 28;2022:9212253. doi: 10.1155/2022/9212253. eCollection 2022.
PubMed 35388352
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Implantable Phakic Intraocular Lens and Implantable Collamer Lens in Treatment of Myopia in Adults
- ClinicalTrials.gov ID
- NCT04624035
- Acronym / sponsor ID
- ICL vs IPCL
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 10 Nov 2020 (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.
Phakic intraocular lenses (pIOL) of different designs and materials have been used effectively instead of corneal refractive surgery in certain situations. The pIOL exhibits a number of advantages over corneal techniques as it is suitable for high myopes, with lower production of aberrations, and superior contrast sensitivity. Keeping the accommodation is its definite lead over refractive lens exchange. The Visian implantable collamer lens (ICL; Staar Surgical, Monrovia, CA), a posterior chamber pIOL, has been stated to be useful for the correction of high myopia. Nevertheless, as an intraocular procedure, it is associated with a risk of complications as probable injury to anterior segment, retinal detachment and endophthalmitis.
The Implantable Phakic Contact Lens (IPCL V2, Caregroup Sight Solutions, India) has been developed as an alternative for the ICL, at a noticeable financial advantage. Furthermore, the highestmyopic correction which is instantly accessible with ICL is -18.0 D. Meanwhile, IPCL can provide correction higher degrees up to -30.0 D.
Former researches have been made to assess the safety and efficiency of ICL implantation, to evaluate various devices for anterior segment imaging postoperatively and to identify changes in anterior segment after surgery. A recent study determined the safety of the IPCL over a minimum follow-up period of one year. In this work the investigators aimed to compare the refractive results and the adverse effects of the IPCL and the ICL in treatment of myopia in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implantable Collamer Lens (ICL, V4c with central hole) in treatment of myopia in adults. | Active comparator | Procedure: Implantable Collamer Lens (ICL) in treatment of myopia in adults.Implantation of ICL (V4c with central hole) for treatment of myopia in adults using peribulbar anesthesia. Thirty minutes before surgery, cycloplegic and phenylephrine eye drops were applied. Five minutes before surgery, povidone-iodine 5% was applied. The anterior chamber was filled with sodium hyaluronate 1%, which was completely removed at the end of the surgery. The lens was inserted using the ICL injector. Tobramycin and dexamethasone 0.1% eye drops were used four times a day for 10 days, after which diclofenac sodium eye drops were started four times a day for 2 weeks. |
| Acrylic Implantable Intraocular Lens (IPCL, V2) in treatment of myopia in adults | Active comparator | Procedure: Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.Implantation of IPCL for treatment of Myopia in adults using peribulbar anesthesia. Thirty minutes before surgery, cycloplegic and phenylephrine eye drops were applied. Five minutes before surgery, povidone-iodine 5% was applied. The anterior chamber was filled with sodium hyaluronate 1%, which was completely removed at the end of the surgery. The lens was inserted using the IPCL injector. Tobramycin and dexamethasone 0.1% eye drops were used four times a day for 10 days, after which diclofenac sodium eye drops were started four times a day for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- myopia of more than 6 diopter
- central anterior chamber depth more than 2.8 mm
Key exclusion criteria (3 listed)
- unstable refraction
- any other ocular disease
- any systemic disease
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 |
|---|---|---|
| Implantable Collamer Lens (ICL) in treatment of myopia in adults.Also: All drugs used were mentioned in the arm descriptionICL Group: After mydriatic eye drops and topical anesthesia instillation, a 3-mm temporal corneal incision was done. Viscoelastic material was injected in the anterior chamber (AC). An injector cartridge (STAAR Surgical) was used to insert the ICL V4c model with central hole). The four footplates of the ICL were positioned on the ciliary sulcus at the 180° axis. Viscoelastic material was entirely taken away. | Procedure or surgery | Implantable Collamer Lens (ICL, V4c with central hole) in treatment of myopia in adults. |
| Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.Also: All drugs used were mentioned in the arm descriptionIPCL Group: Topical anesthetic and mydriatic agents were instilled before surgery. Using peripulbar anaesthesia, the IPCL (V2 model with central hole) was implanted into the AC through a 3 mm clear corneal incision after viscoelastic material injection. The footplates were subsequently tucked behind the iris, followed by a thorough viscoelastic removal. | Procedure or surgery | Acrylic Implantable Intraocular Lens (IPCL, V2) in treatment of myopia in adults |
Primary outcome
Refractive outcome
Time frame: 12 months
Postoperative refractive error measured in spherical equivalent
Visual outcome
Time frame: 12 months
Uncorrected distance and near vision using Snellen's chart and using decimal fractions
1 secondary outcome
Adverse reactions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 18031820Stulting RD, John ME, Maloney RK, Assil KK, Arrowsmith PN, Thompson VM; U.S. Verisyse Study Group. Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial. Ophthalmology. 2008 Mar;115(3):464-472.e1. doi: 10.1016/j.ophtha.2007.08.039. Epub 2007 Nov 26.
- Background: PubMed 22365084Kamiya K, Igarashi A, Shimizu K, Matsumura K, Komatsu M. Visual performance after posterior chamber phakic intraocular lens implantation and wavefront-guided laser in situ keratomileusis for low to moderate myopia. Am J Ophthalmol. 2012 Jun;153(6):1178-86.e1. doi: 10.1016/j.ajo.2011.12.005. Epub 2012 Feb 23.
- Background: PubMed 17172886Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.
- Background: PubMed 19375059Igarashi A, Kamiya K, Shimizu K, Komatsu M. Visual performance after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis for high myopia. Am J Ophthalmol. 2009 Jul;148(1):164-70.e1. doi: 10.1016/j.ajo.2009.02.001. Epub 2009 Apr 17.
- Background: PubMed 15519075Pineda-Fernandez A, Jaramillo J, Vargas J, Jaramillo M, Jaramillo J, Galindez A. Phakic posterior chamber intraocular lens for high myopia. J Cataract Refract Surg. 2004 Nov;30(11):2277-83. doi: 10.1016/j.jcrs.2004.03.035.
- Background: PubMed 28933042Elmohamady MN, Abdelghaffar W. Anterior Chamber Changes After Implantable Collamer Lens Implantation in High Myopia Using Pentacam: A Prospective Study. Ophthalmol Ther. 2017 Dec;6(2):343-349. doi: 10.1007/s40123-017-0109-3. Epub 2017 Sep 20.
- Background: PubMed 21710954Fernandes P, Gonzalez-Meijome JM, Madrid-Costa D, Ferrer-Blasco T, Jorge J, Montes-Mico R. Implantable collamer posterior chamber intraocular lenses: a review of potential complications. J Refract Surg. 2011 Oct;27(10):765-76. doi: 10.3928/1081597X-20110617-01. Epub 2011 Jun 30.
- Background: PubMed 30662257Sachdev G, Ramamurthy D. Long-term safety of posterior chamber implantable phakic contact lens for the correction of myopia. Clin Ophthalmol. 2019 Jan 7;13:137-142. doi: 10.2147/OPTH.S185304. eCollection 2019.
- Background: PubMed 26949611Zhang J, Luo HH, Zhuang J, Yu KM. Comparison of anterior section parameters using anterior segment optical coherence tomography and ultrasound biomicroscopy in myopic patients after ICL implantation. Int J Ophthalmol. 2016 Jan 18;9(1):58-62. doi: 10.18240/ijo.2016.01.10. eCollection 2016.
- Derived from this study: PubMed 35388352Rateb M, Gad AAM, Tohamy D, Elmohamady MN. A Prospective Comparative Study between Implantable Phakic Intraocular Contact Lens and Implantable Collamer Lens in Treatment of Myopia in Adults. J Ophthalmol. 2022 Mar 28;2022:9212253. doi: 10.1155/2022/9212253. eCollection 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data that underline the results of this trial will be available once completion of the study after de-identification.
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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.
Mahmoud F Rateb, MD principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Collamer Lens (ICL) in treatment of myopia in adults. and Implantable Intraocular Lens (IPCL) in treatment of myopia in adults. in people with Myopia, run by Assiut University at 2 sites 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud F Rateb, MD (+20 100 8348480, rateb@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive outcome (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT04624035, which also lists 10 linked publications.
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 10 Nov 2020.