Macular HolesNCT06233500
Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
A study testing pars plana vitrectomy in people with Macular Holes, run by Fayoum University at 1 site in Egypt.
Trial summary
The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole. The main questions it aims to answer are: What are the macular micro vascular and structural changes pre and post repair of idiopathic full… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Macular Holes
- What is being tested?
- pars plana vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 15 Mar 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic full thickness Macular hole without retinal detachment
Who cannot join
- Previous pars plana vitrectomy
- High myopia with axial length ≥ 26 mm.
- Uncertain symptom duration or ≥ 6 month .
- History of same eye trauma
- Poor image quality.
- Patients with diabetic retinopathy or other retinal diseases, e.g. ischemic, inflammatory.
- Any patient with significant cataract which needs combined phaco-vitrectomy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
research institute of ophthalmology, Egypt
Giza, 12511
Abeer Salem, +201125666006, A.salem@Rio.edu.eg
Heba Ahmed, +201020020157, heba_rio2000@yahoo.com
About this study
The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole.
The main questions it aims to answer are:
Read more
- What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery.
- Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively.
- What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap.
Participants will be:
- Subjected to pars plana vitrectomy to repair macular hole.
- Examined by optical coherence tomography angiography pre and post operative
Researchers will compare:
Group A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.
Read the detailed description
This study will include 28 eyes with idiopathic full thickness macular hole; they will be divided into two groups:
Group A: 14 eyes will be treated without ILM flap Group B : 14 eyes will be treated by ILM flap
- Sample size: 28 eyes. (based on ELM recovery rate in ILM flap 70% versus 21.4% with inverted flap (Iwasaki et al., 2019), and at power of study 80% and confidence level 95%, sample size is calculated using openEpi software to be 14 eyes in each group
- Study setting: Ophthalmology Department, Fayoum University and the Research Institute of Ophthalmology
- Data Collection :
- History :
- Demographic data ( age , gender )
- General medical history ( DM, HTN )
- Symptom duration
- Previous ocular history
- Clinical examination:
- Best corrected visual acuity using snellen chart (converted to log MAR for statiscal analysis).
- Slit lamp biomicroscopy for anterior segment examination.
- Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
- Axial length measurement
- Optical Coherence Tomography:
We use SD- OCT and OCTA for pre and post-operative evaluation of retinal layers microstructure and vasculature.
- Surgical Procedure
All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:
- 23 G trocar system will be used
- Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done
- Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling
Patients will be divided then into two groups:
Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done
- Shaving of the vitreous base, and then fluid air exchange
- SF 6 gas tamponade will be used
- Study procedures:
- Regular clinical assessment pre and at 1 and 6 months post-operative including:
- Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
- Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
- Standard Optical coherence tomography of the macula at 1 and 6 months post-operative using (SD-OCT) scans (512 A-scans, 20°×20°) with the following protocol:
Macula thickness map for measurement of central retinal thickness, and photoreceptor inner segment/outer segment complex.
- Optical coherence tomography angiography of the macula at 1 and 6 months post-operative studying Superficial Capillary plexus, Deep Capillary plexus and Fovea avascular zone.
- Conditions
- Macular Holes
- Being tested
- pars plana vitrectomy
- Keywords
- macular hole, ILM peeling, Temporal flap, OCTA, Optical Coherence Tomography Angiography
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomyProcedure or surgery
Also called PPV with ILM peeling
All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:
- 23 G trocar system will be used
- Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done
- Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling
Patients will be divided then into two groups:
Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done
- Shaving of the vitreous base, and then fluid air exchange
- SF 6 gas tamponade will be used
| Study group | Role | What they receive |
|---|---|---|
| Group A: eyes will be treated without ILM flap | Active comparator | Group A: Only wide ILM peeling up to the arcades well be done Receives: Procedure: pars plana vitrectomy |
| Group B : eyes will be treated by ILM flap | Active comparator | Group B: ILM peeling with flap well be done Receives: Procedure: pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
Measured: It will be measured preoperative and at 1 and 6 months post-operative
Fovea avascular zone FAZ
Optical coherence tomography angiography used to measure FAZ area in mm2 (mm square)
Measured: It will be measured preoperative and at 1 and 6 months post-operative
Secondary outcomes (1)
central retinal thickness
Standard Optical coherence tomography of the macula using (SD-OCT) scans (512 A-scans, 20°×20°) to measure central retinal thickness in µm
Measured: It will be measured preoperative and at 1 and 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Dec 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Model description
- This study will include 28 eyes with idiopathic full thickness macular hole; All eyes in this study will be subjected to pars plana vitrectomy procedure, they will be divided into two groups: Group A: 16 eyes will be treated with only wide internal limiting membrane (ILM) peeling up to the arcades without ILM flap Group B : 16 eyes will be treated by ILM peeling with ILM flap.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute of Ophthalmology, Egypt
- Responsible party
- Principal investigator, Mohamed Hussein, Fayoum University
- Investigators
- Islam Mohalhal, MD, Study director, Research Institute of Ophthalmology, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233500
- Sponsor's protocol ID
- FayoumU_28
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Publications
Demirel S, Degirmenci MFK, Bilici S, Yanik O, Batioglu F, Ozmert E, Alp N. The Recovery of Microvascular Status Evaluated by Optical Coherence Tomography Angiography in Patients after Successful Macular Hole Surgery. Ophthalmic Res. 2018;59(1):53-57. doi: 10.1159/000484092. Epub 2017 Nov 29.
PubMed 29183023Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. doi: 10.1001/archopht.1991.01080050068031.
PubMed 2025167Lai MM, Williams GA. Anatomical and visual outcomes of idiopathic macular hole surgery with internal limiting membrane removal using low-concentration indocyanine green. Retina. 2007 Apr-May;27(4):477-82. doi: 10.1097/01.iae.0000247166.11120.21.
PubMed 17420702Casini G, Mura M, Figus M, Loiudice P, Peiretti E, De Cilla S, Fuentes T, Nasini F. INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE FOR MACULAR HOLE SURGERY WITHOUT EXTRA MANIPULATION OF THE FLAP. Retina. 2017 Nov;37(11):2138-2144. doi: 10.1097/IAE.0000000000001470.
PubMed 28129215Yun C, Ahn J, Kim M, Kim JT, Hwang SY, Kim SW, Oh J. Characteristics of retinal vessels in surgically closed macular hole: an optical coherence tomography angiography study. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1923-1934. doi: 10.1007/s00417-017-3742-6. Epub 2017 Jul 25.
PubMed 28744658Woon WH, Greig D, Savage MD, Wilson MC, Grant CA, Mokete B, Bishop F. Movement of the inner retina complex during the development of primary full-thickness macular holes: implications for hypotheses of pathogenesis. Graefes Arch Clin Exp Ophthalmol. 2015 Dec;253(12):2103-9. doi: 10.1007/s00417-015-2951-0. Epub 2015 Feb 13.
PubMed 25673252Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973.
PubMed 24736052Spaide RF, Klancnik JM Jr, Cooney MJ. Retinal vascular layers imaged by fluorescein angiography and optical coherence tomography angiography. JAMA Ophthalmol. 2015 Jan;133(1):45-50. doi: 10.1001/jamaophthalmol.2014.3616.
PubMed 25317632Lupidi M, Coscas F, Cagini C, Fiore T, Spaccini E, Fruttini D, Coscas G. Automated Quantitative Analysis of Retinal Microvasculature in Normal Eyes on Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 Sep;169:9-23. doi: 10.1016/j.ajo.2016.06.008. Epub 2016 Jun 11.
PubMed 27296485Samara WA, Say EA, Khoo CT, Higgins TP, Magrath G, Ferenczy S, Shields CL. CORRELATION OF FOVEAL AVASCULAR ZONE SIZE WITH FOVEAL MORPHOLOGY IN NORMAL EYES USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2188-95. doi: 10.1097/IAE.0000000000000847.
PubMed 26469536Kim YJ, Jo J, Lee JY, Yoon YH, Kim JG. Macular capillary plexuses after macular hole surgery: an optical coherence tomography angiography study. Br J Ophthalmol. 2018 Jul;102(7):966-970. doi: 10.1136/bjophthalmol-2017-311132. Epub 2017 Oct 5.
PubMed 28982954
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
- ClinicalTrials.gov ID
- NCT06233500
- Acronym / sponsor ID
- FayoumU_28
- Conditions
- Macular Holes
- Keywords
- macular hole, ILM peeling, Temporal flap, OCTA, Optical Coherence Tomography Angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Collaborators
- Research Institute of Ophthalmology, Egypt
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 31 Jan 2024 (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.
The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole.
The main questions it aims to answer are:
- What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery.
- Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively.
- What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap.
Participants will be:
- Subjected to pars plana vitrectomy to repair macular hole.
- Examined by optical coherence tomography angiography pre and post operative
Researchers will compare:
Group A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.
Detailed description
This study will include 28 eyes with idiopathic full thickness macular hole; they will be divided into two groups:
Group A: 14 eyes will be treated without ILM flap Group B : 14 eyes will be treated by ILM flap
- Sample size: 28 eyes. (based on ELM recovery rate in ILM flap 70% versus 21.4% with inverted flap (Iwasaki et al., 2019), and at power of study 80% and confidence level 95%, sample size is calculated using openEpi software to be 14 eyes in each group
- Study setting: Ophthalmology Department, Fayoum University and the Research Institute of Ophthalmology
- Data Collection :
- History :
- Demographic data ( age , gender )
- General medical history ( DM, HTN )
- Symptom duration
- Previous ocular history
- Clinical examination:
- Best corrected visual acuity using snellen chart (converted to log MAR for statiscal analysis).
- Slit lamp biomicroscopy for anterior segment examination.
- Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
- Axial length measurement
- Optical Coherence Tomography:
We use SD- OCT and OCTA for pre and post-operative evaluation of retinal layers microstructure and vasculature.
- Surgical Procedure
All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:
- 23 G trocar system will be used
- Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done
- Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling
Patients will be divided then into two groups:
Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done
- Shaving of the vitreous base, and then fluid air exchange
- SF 6 gas tamponade will be used
- Study procedures:
- Regular clinical assessment pre and at 1 and 6 months post-operative including:
- Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
- Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
- Standard Optical coherence tomography of the macula at 1 and 6 months post-operative using (SD-OCT) scans (512 A-scans, 20°×20°) with the following protocol:
Macula thickness map for measurement of central retinal thickness, and photoreceptor inner segment/outer segment complex.
- Optical coherence tomography angiography of the macula at 1 and 6 months post-operative studying Superficial Capillary plexus, Deep Capillary plexus and Fovea avascular zone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will include 28 eyes with idiopathic full thickness macular hole; All eyes in this study will be subjected to pars plana vitrectomy procedure, they will be divided into two groups: Group A: 16 eyes will be treated with only wide internal limiting membrane (ILM) peeling up to the arcades without ILM flap Group B : 16 eyes will be treated by ILM peeling with ILM flap.
| Arm | Type | Receives |
|---|---|---|
| Group A: eyes will be treated without ILM flap | Active comparator | Procedure: pars plana vitrectomyGroup A: Only wide ILM peeling up to the arcades well be done |
| Group B : eyes will be treated by ILM flap | Active comparator | Procedure: pars plana vitrectomyGroup B: ILM peeling with flap well be done |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic full thickness Macular hole without retinal detachment
Key exclusion criteria (7 listed)
- Previous pars plana vitrectomy
- High myopia with axial length ≥ 26 mm.
- Uncertain symptom duration or ≥ 6 month .
- History of same eye trauma
- Poor image quality.
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 |
|---|---|---|
| pars plana vitrectomyAlso: PPV with ILM peelingAll eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps: * 23 G trocar system will be used * Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done * Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling Patients will be divided then into two groups: Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done * Shaving of the vitreous base, and then fluid air exchange * SF 6 gas tamponade will be used | Procedure or surgery | Group A: eyes will be treated without ILM flap, Group B : eyes will be treated by ILM flap |
Primary outcome
visual acuity
Time frame: It will be measured preoperative and at 1 and 6 months post-operative
Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
Fovea avascular zone FAZ
Time frame: It will be measured preoperative and at 1 and 6 months post-operative
Optical coherence tomography angiography used to measure FAZ area in mm2 (mm square)
1 secondary outcome
central retinal thickness
Time frame: It will be measured preoperative and at 1 and 6 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 29183023Demirel S, Degirmenci MFK, Bilici S, Yanik O, Batioglu F, Ozmert E, Alp N. The Recovery of Microvascular Status Evaluated by Optical Coherence Tomography Angiography in Patients after Successful Macular Hole Surgery. Ophthalmic Res. 2018;59(1):53-57. doi: 10.1159/000484092. Epub 2017 Nov 29.
- Background: PubMed 2025167Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. doi: 10.1001/archopht.1991.01080050068031.
- Background: PubMed 17420702Lai MM, Williams GA. Anatomical and visual outcomes of idiopathic macular hole surgery with internal limiting membrane removal using low-concentration indocyanine green. Retina. 2007 Apr-May;27(4):477-82. doi: 10.1097/01.iae.0000247166.11120.21.
- Background: PubMed 28129215Casini G, Mura M, Figus M, Loiudice P, Peiretti E, De Cilla S, Fuentes T, Nasini F. INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE FOR MACULAR HOLE SURGERY WITHOUT EXTRA MANIPULATION OF THE FLAP. Retina. 2017 Nov;37(11):2138-2144. doi: 10.1097/IAE.0000000000001470.
- Background: PubMed 28744658Yun C, Ahn J, Kim M, Kim JT, Hwang SY, Kim SW, Oh J. Characteristics of retinal vessels in surgically closed macular hole: an optical coherence tomography angiography study. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1923-1934. doi: 10.1007/s00417-017-3742-6. Epub 2017 Jul 25.
- Background: PubMed 25673252Woon WH, Greig D, Savage MD, Wilson MC, Grant CA, Mokete B, Bishop F. Movement of the inner retina complex during the development of primary full-thickness macular holes: implications for hypotheses of pathogenesis. Graefes Arch Clin Exp Ophthalmol. 2015 Dec;253(12):2103-9. doi: 10.1007/s00417-015-2951-0. Epub 2015 Feb 13.
- Background: PubMed 24736052Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973.
- Background: PubMed 25317632Spaide RF, Klancnik JM Jr, Cooney MJ. Retinal vascular layers imaged by fluorescein angiography and optical coherence tomography angiography. JAMA Ophthalmol. 2015 Jan;133(1):45-50. doi: 10.1001/jamaophthalmol.2014.3616.
- Background: PubMed 27296485Lupidi M, Coscas F, Cagini C, Fiore T, Spaccini E, Fruttini D, Coscas G. Automated Quantitative Analysis of Retinal Microvasculature in Normal Eyes on Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 Sep;169:9-23. doi: 10.1016/j.ajo.2016.06.008. Epub 2016 Jun 11.
- Background: PubMed 26469536Samara WA, Say EA, Khoo CT, Higgins TP, Magrath G, Ferenczy S, Shields CL. CORRELATION OF FOVEAL AVASCULAR ZONE SIZE WITH FOVEAL MORPHOLOGY IN NORMAL EYES USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2188-95. doi: 10.1097/IAE.0000000000000847.
- Background: PubMed 28982954Kim YJ, Jo J, Lee JY, Yoon YH, Kim JG. Macular capillary plexuses after macular hole surgery: an optical coherence tomography angiography study. Br J Ophthalmol. 2018 Jul;102(7):966-970. doi: 10.1136/bjophthalmol-2017-311132. Epub 2017 Oct 5.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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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.
Islam Mohalhal, MD study director
Research Institute of Ophthalmology, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pars plana vitrectomy in people with Macular Holes, run by Fayoum 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 1 inclusion and 7 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 31 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Husssein (+201015479856, mhmm1004@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: It will be measured preoperative and at 1 and 6 months post-operative). 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 NCT06233500, which also lists 11 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 31 Jan 2024.