Correction of Refractive Error Surprises After Cataract Surgery in Adults

NCT ID: NCT06379477

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-06-30

Brief Summary

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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

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Aim(s) of the Research:

1. detection of refractive surprises using autorefractometer, and corneal topography.
2. treatment of the resulting refractive error surprises.

Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Corneal refractive surgery

Among patients scheduled for cataract surgery, Group I; will undergo Corneal refractive surgery to correct any post-operative refractive surprises.

Group Type ACTIVE_COMPARATOR

Refractive surgeries

Intervention Type PROCEDURE

after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options

IOL exchange

Among patients scheduled for cataract surgery, Group II; will undergo IOL exchange to correct any post-operative refractive surprises.

Group Type ACTIVE_COMPARATOR

Refractive surgeries

Intervention Type PROCEDURE

after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options

Piggyback sulcus IOL

Among patients scheduled for cataract surgery, Group III; will undergo Piggyback sulcus IOL to correct any post-operative refractive surprises.

Group Type ACTIVE_COMPARATOR

Refractive surgeries

Intervention Type PROCEDURE

after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options

Interventions

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Refractive surgeries

after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* Patients with complicated cataract.
* Raised intraocular pressure (IOP).
* Patients with pathologies of the posterior segment of the eye.
* Other causes of diminution of vision.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Mohamed saad

ophthalmology specialist at ophthalmology department Assiut University hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdy M Mostafa, MD

Role: STUDY_DIRECTOR

Assiut University

Mohamed S Hussien, MD

Role: STUDY_DIRECTOR

Assiut University

Ali N Ryad, MD

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Abdelrahman M Saad, MSC

Role: CONTACT

+201067895256

References

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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.

Reference Type BACKGROUND
PMID: 26605349 (View on PubMed)

Day 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.

Reference Type RESULT
PMID: 25679413 (View on PubMed)

Gale 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.

Reference Type RESULT
PMID: 17721503 (View on PubMed)

Khoramnia 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.

Reference Type RESULT
PMID: 35204334 (View on PubMed)

Moshirfar 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.

Reference Type RESULT
PMID: 33122488 (View on PubMed)

Ladas 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.

Reference Type RESULT
PMID: 21889661 (View on PubMed)

Iwase 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.

Reference Type RESULT
PMID: 18465719 (View on PubMed)

Other Identifiers

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refractive error surprises

Identifier Type: -

Identifier Source: org_study_id

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