Refractive ErrorsNCT06379477
Correction of Refractive Error Surprises After Cataract Surgery in Adults
A study testing Refractive surgeries in people with Refractive Errors, run by Assiut University.
Trial summary
A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Refractive surgeries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Jun 2025
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients scheduled for cataract surgery with:
- Symptomatizing patients with postoperative spherical error of more than 1 diopters.
- Symptomatizing patients with postoperative cylindrical error of more than 1 diopters.
- Symptomatizing patients with uncorrected distant visual acuity less than 6/24
- Symptomatizing patients with corrected distant visual acuity of less than 6/12
- Clear cornea. 6. Uneventful surgery.
Who cannot join
- Patients with complicated cataract.
- Raised intraocular pressure (IOP).
- Patients with pathologies of the posterior segment of the eye.
- Other causes of diminution of vision.
Trial locations and contacts
No sites are listed yet.
About this study
A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery.
Read the detailed description
Aim(s) of the Research:
- detection of refractive surprises using autorefractometer, and corneal topography.
- treatment of the resulting refractive error surprises.
- Conditions
- Refractive Errors
- Being tested
- Refractive surgeries
- Keywords
- refractive error surprises
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refractive surgeriesProcedure or surgery
after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options
| Study group | Role | What they receive |
|---|---|---|
| Corneal refractive surgery | Active comparator | Among patients scheduled for cataract surgery, Group I; will undergo Corneal refractive surgery to correct any post-operative refractive surprises. Receives: Procedure: Refractive surgeries |
| IOL exchange | Active comparator | Among patients scheduled for cataract surgery, Group II; will undergo IOL exchange to correct any post-operative refractive surprises. Receives: Procedure: Refractive surgeries |
| Piggyback sulcus IOL | Active comparator | Among patients scheduled for cataract surgery, Group III; will undergo Piggyback sulcus IOL to correct any post-operative refractive surprises. Receives: Procedure: Refractive surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis and treatment of the resulting refractive error surprises
Rate of refractive error surprises
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed saad, Assiut University
- Investigators
- Magdy M Mostafa, MD, Study director, Assiut UniversityMohamed S Hussien, MD, Study director, Assiut UniversityAli N Ryad, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379477
- Sponsor's protocol ID
- refractive error surprises
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelghany AA, Alio JL. Surgical options for correction of refractive error following cataract surgery. Eye Vis (Lond). 2014 Oct 16;1:2. doi: 10.1186/s40662-014-0002-2. eCollection 2014.
PubMed 26605349Day AC, Donachie PH, Sparrow JM, Johnston RL; Royal College of Ophthalmologists' National Ophthalmology Database. The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 1, visual outcomes and complications. Eye (Lond). 2015 Apr;29(4):552-60. doi: 10.1038/eye.2015.3. Epub 2015 Feb 13.
PubMed 25679413Gale RP, Saldana M, Johnston RL, Zuberbuhler B, McKibbin M. Benchmark standards for refractive outcomes after NHS cataract surgery. Eye (Lond). 2009 Jan;23(1):149-52. doi: 10.1038/sj.eye.6702954. Epub 2007 Aug 24.
PubMed 17721503Khoramnia R, Auffarth G, Labuz G, Pettit G, Suryakumar R. Refractive Outcomes after Cataract Surgery. Diagnostics (Basel). 2022 Jan 19;12(2):243. doi: 10.3390/diagnostics12020243.
PubMed 35204334Moshirfar M, Thomson AC, Thomson RJ, Martheswaran T, McCabe SE. Refractive enhancements for residual refractive error after cataract surgery. Curr Opin Ophthalmol. 2021 Jan;32(1):54-61. doi: 10.1097/ICU.0000000000000717.
PubMed 33122488Ladas JG, Stark WJ. Improving cataract surgery refractive outcomes. Ophthalmology. 2011 Sep;118(9):1699-700. doi: 10.1016/j.ophtha.2011.05.038. No abstract available.
PubMed 21889661Iwase T, Tanaka N, Sugiyama K. Postoperative refraction changes in phacoemulsification cataract surgery with implantation of different types of intraocular lens. Eur J Ophthalmol. 2008 May-Jun;18(3):371-6. doi: 10.1177/112067210801800310.
PubMed 18465719
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Refractive Error Surprises After Cataract Surgery in Adults
- ClinicalTrials.gov ID
- NCT06379477
- Acronym / sponsor ID
- refractive error surprises
- Conditions
- Refractive Errors
- Keywords
- refractive error surprises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Apr 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.
A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery.
Detailed description
Aim(s) of the Research:
- detection of refractive surprises using autorefractometer, and corneal topography.
- treatment of the resulting refractive error surprises.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corneal refractive surgery | Active comparator | Procedure: Refractive surgeriesAmong patients scheduled for cataract surgery, Group I; will undergo Corneal refractive surgery to correct any post-operative refractive surprises. |
| IOL exchange | Active comparator | Procedure: Refractive surgeriesAmong patients scheduled for cataract surgery, Group II; will undergo IOL exchange to correct any post-operative refractive surprises. |
| Piggyback sulcus IOL | Active comparator | Procedure: Refractive surgeriesAmong patients scheduled for cataract surgery, Group III; will undergo Piggyback sulcus IOL to correct any post-operative refractive surprises. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatizing patients with postoperative spherical error of more than 1 diopters.
- Symptomatizing patients with postoperative cylindrical error of more than 1 diopters.
- Symptomatizing patients with uncorrected distant visual acuity less than 6/24
- Symptomatizing patients with corrected distant visual acuity of less than 6/12
- Clear cornea. 6. Uneventful surgery.
Key exclusion criteria (4 listed)
- Patients with complicated cataract.
- Raised intraocular pressure (IOP).
- Patients with pathologies of the posterior segment of the eye.
- Other causes of diminution of vision.
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 |
|---|---|---|
| Refractive surgeriesafter primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options | Procedure or surgery | Corneal refractive surgery, IOL exchange, Piggyback sulcus IOL |
Primary outcome
Diagnosis and treatment of the resulting refractive error surprises
Time frame: Baseline
Rate of refractive error surprises
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 26605349Abdelghany AA, Alio JL. Surgical options for correction of refractive error following cataract surgery. Eye Vis (Lond). 2014 Oct 16;1:2. doi: 10.1186/s40662-014-0002-2. eCollection 2014.
- Results publication: PubMed 25679413Day AC, Donachie PH, Sparrow JM, Johnston RL; Royal College of Ophthalmologists' National Ophthalmology Database. The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 1, visual outcomes and complications. Eye (Lond). 2015 Apr;29(4):552-60. doi: 10.1038/eye.2015.3. Epub 2015 Feb 13.
- Results publication: PubMed 17721503Gale RP, Saldana M, Johnston RL, Zuberbuhler B, McKibbin M. Benchmark standards for refractive outcomes after NHS cataract surgery. Eye (Lond). 2009 Jan;23(1):149-52. doi: 10.1038/sj.eye.6702954. Epub 2007 Aug 24.
- Results publication: PubMed 35204334Khoramnia R, Auffarth G, Labuz G, Pettit G, Suryakumar R. Refractive Outcomes after Cataract Surgery. Diagnostics (Basel). 2022 Jan 19;12(2):243. doi: 10.3390/diagnostics12020243.
- Results publication: PubMed 33122488Moshirfar M, Thomson AC, Thomson RJ, Martheswaran T, McCabe SE. Refractive enhancements for residual refractive error after cataract surgery. Curr Opin Ophthalmol. 2021 Jan;32(1):54-61. doi: 10.1097/ICU.0000000000000717.
- Results publication: PubMed 21889661Ladas JG, Stark WJ. Improving cataract surgery refractive outcomes. Ophthalmology. 2011 Sep;118(9):1699-700. doi: 10.1016/j.ophtha.2011.05.038. No abstract available.
- Results publication: PubMed 18465719Iwase T, Tanaka N, Sugiyama K. Postoperative refraction changes in phacoemulsification cataract surgery with implantation of different types of intraocular lens. Eur J Ophthalmol. 2008 May-Jun;18(3):371-6. doi: 10.1177/112067210801800310.
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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.
Magdy M Mostafa, MD study director
Assiut University
Mohamed S Hussien, MD study director
Assiut University
Ali N Ryad, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Refractive surgeries in people with Refractive Errors, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Abdelrahman M Saad, MSC (+201067895256, arabasdm.23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis and treatment of the resulting refractive error surprises (time frame: Baseline). 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 NCT06379477, which also lists 7 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 23 Apr 2024.